Request Demo

Last update 03 Aug 2026

Fulvestrant

Last update 03 Aug 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(7α,17β)-7-{9-[(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl}estra-1(10),2,4-triene-3,17-diol, Fulvestrant (JAN/USP/INN), Oral fulvestrant (VeraMorph)

+ [21]

Target

Action

antagonists

Mechanism

ERs antagonists(Estrogen receptors antagonists)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesEndocrinology and Metabolic Disease+ [1]

Active Indication

Advanced breast cancerMetastatic breast cancerHormone Receptor Positive Breast Adenocarcinoma+ [28]

Inactive Indication

Advanced cancerAdvanced Lung Non-Small Cell CarcinomaAdvanced Malignant Solid Neoplasm+ [28]

Originator Organization

AstraZeneca PLC

Active Organization

Roche Holding AG

Eli Lilly & Co.

Fresenius Kabi USA LLC

+ [17]

Inactive Organization

Celcuity, Inc.Xynomic Pharmaceuticals, Inc.

Genentech, Inc.

+ [3]

License Organization

Zymeworks, Inc.

Boryung Corp.

Pfizer Inc.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (25 Apr 2002),

Hormone receptor positive breast cancer

RegulationPriority Review (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC32H47F5O3S

InChIKeyVWUXBMIQPBEWFH-WCCTWKNTSA-N

CAS Registry129453-61-8

542

Clinical Trials associated with Fulvestrant

NCT07729046

/ Not yet recruitingPhase 2IIT

Neu Direction: A Single Center Phase II Randomized Clinical Trial to Assess the Efficacy of Adding HER Inhibition to Standard of Care in Patients With Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast Cancer

The goal of this clinical trial is to learn if neratinib, an FDA-approved oral pan-HER2/3/4 inhibitor, improves disease control for participants with metastatic endocrine-resistant ER+/HER2-negative breast cancer. Neratinib is already approved for the treatment of HER2-postive breast cancers. The study will also learn about the safety of adding this drug to standard of care treatments. The main questions it aims to answer are:
1. Does adding neratinib to standard of care systemic therapy improve disease control for patients with metastatic hormone-driven breast cancer that is resistant to endocrine therapy?
2. What side effects do participants have when adding neratinib to standard of care therapy? Researchers will compare standard of care endocrine therapy regimens with and without neratinib to see if neratinib improves control of treatment-resistant metastatic breast cancer that has continued to progress while eon first line endocrine therapy.
Participants will:
1. Take standard of care endocrine therapy for metastatic endocrine-resistant breast cancer as determined by their medical oncologist or standard of care therapy with neratinib daily
2. Visit the clinic every 3 months for checkups, tests and imaging studies

Start Date01 Jul 2027

Sponsor / Collaborator

University of California San Diego

NCT07679269

/ Not yet recruitingPhase 2

An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.

The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.

Start Date01 Jan 2027

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT07619066

/ Not yet recruitingPhase 2

A Two-stage, Single-arm Phase II Study of Zongertinib Plus Fulvestrant in Participants With Hormone Receptor-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.

An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive/HER2-negative advanced breast cancer harboring HER2 mutations.

Start Date04 Oct 2026

Sponsor / Collaborator

Medica Scientia Innovation Research SL

[+1]

100 Clinical Results associated with Fulvestrant

100 Translational Medicine associated with Fulvestrant

100 Patents (Medical) associated with Fulvestrant

5,668

Literatures (Medical) associated with Fulvestrant

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of capivasertib plus fulvestrant in the PIK3CA/AKT1/PTEN -altered subgroup with HR+/HER2− advanced breast cancer: a United States payer perspective

Article

Author: Tan, Chia Jie ; Liang, Xi ; Malone, Daniel C.

AIMS:

Capivasertib plus fulvestrant has emerged as a promising targeted therapy for HR+/HER2- advanced breast cancer (ABC). This study evaluated the cost-effectiveness of capivasertib plus fulvestrant vs. fulvestrant monotherapy in PI3K/AKT/PTEN pathway-altered patients with HR+/HER2- ABC from a U.S. payer's perspective.

MATERIALS AND METHODS:

A partitioned survival model with three health states (progression-free, progressive disease, and death) was developed over a 5-year time horizon. Progression-free survival (PFS) and overall survival (OS) data were derived from the CAPItello-291 trial (NCT04305496). Utility, disutility, and direct medical costs were obtained from published literature and the Centers for Medicare and Medicaid Services. Capivasertib cost was based on wholesale acquisition cost. Costs were presented in 2025 U.S. dollars. Both costs and outcomes were discounted by 3%. Incremental cost-effectiveness ratios (ICERs) based on quality-adjusted life-year (QALY) gained and equal value of life years gained (evLYG) were compared using a willingness-to-pay (WTP) threshold of $150,000. Sensitivity analyses, scenario analyses (10-year horizon and phase II trial data) and threshold analysis were conducted.

RESULTS:

Capivasertib plus fulvestrant yielded more QALYs (1.89 vs. 1.29) and life years (3.31 vs. 2.49) but higher costs ($539,625 vs. $158,679) than fulvestrant alone, resulting in ICERs of $636,455/QALY gained and $459,358/evLYG over a 5-year time horizon. The cost of capivasertib ($28,332/4 weeks) had the greatest impact and would need to be reduced to $5,598/4 weeks to achieve cost-effectiveness.

LIMITATIONS:

Extrapolation of survival data reflects limited long-term trial data and increases uncertainty surrounding model parameters. Efficacy based on clinical trials may differ from real-world effectiveness.

CONCLUSIONS:

Despite clinical benefits, capivasertib plus fulvestrant was not cost effective at current price from a U.S. payer's perspective. The cost of capivasertib per 4 weeks would be required to decrease by ∼80% from $28,332 to $5,598 (about $87 per 200 mg) to meet the WTP threshold of $150,000.

01 Nov 2026·TISSUE & CELL

Bushen Yijing formula exerts chondroprotective effects in knee osteoarthritis via the ERα/PI3K/AKT signaling pathway: Insights from network pharmacology and experimental validation

Article

Author: Yin, Jian-Li ; Zhai, Yu-Qing ; Zhao, Min-Jun ; Huang, Xin-Hui ; Luo, Jia-Hui ; Yan, Qiang ; Meng, Ting-Ting ; Lu, Jian-Wei ; Huang, Chun-Meng ; Ge, Yang-Shuo ; Du, Jia-Wei ; Ding, Daofang ; Chen, Liao-Lin ; Wang, Xue-Zong

PURPOSE:

The aim of this study is to reveal the molecular mechanisms of BSYJF in KOA treatment through bioinformatics, animal and cellular experiments.

METHODS:

Network pharmacology identified BSYJF's potential active ingredients and targets for KOA treatment, predicting its mechanism of action. In vivo, rats underwent anterior cruciate ligament transection (ACLT) to induce KOA. The therapeutic efficacy of BSYJF was subsequently evaluated using enzyme-linked immunosorbent assay (ELISA), immunohistochemical staining, and micro-computed tomography (Micro-CT). In vitro, chondrocytes were treated with IL-1β to establish an inflammatory model, and BSYJF's protective mechanisms for chondrocytes were subsequently assessed by immunostaining, Western blot (WB), and Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR). Furthermore, we evaluated the binding affinities of its potential active constituents to identified targets using molecular docking.

RESULTS:

Network pharmacology identified 50 active ingredients in BSYJF and 46 hub targets associated with KOA treatment. BSYJF administration significantly reduced serum levels of KOA-related factors (CTX-II, VEGF-A, TNF-α, IL-1β, IL-6) and alleviated abnormal subchondral bone remodeling, as indicated by Micro-CT. Moreover, it downregulated the expression of iNOS and MMP-3 while upregulating Acan and Col2α1 in cartilage tissue, thereby attenuating articular cartilage degeneration. BSYJF-containing serum alleviated IL-1β-induced chondrocyte damage, restoring anabolic markers (Col2α1, Acan, SOX-9) while suppressing catabolic/inflammatory mediators (MMP-3/9/13, ADAMTS5, COX2, VEGF, IL-1β, TNF-α, IL-6). Mechanistically, BSYJF reversed the IL-1β-mediated suppression of ERα expression and PI3K/AKT phosphorylation. This restorative effect was abolished by Fulvestrant (ERα inhibitor), whereas LY294002 (PI3K inhibitor) blocked downstream signaling activation without affecting ERα. RT-qPCR results further confirmed that BSYJF corrected IL-1β-induced dysregulation of targets associated with the PI3K/AKT and estrogen signaling pathways (AKT1, BCL2, MAPK3, EGFR, and ESR1) ERα-dependent manner.

CONCLUSION:

This study demonstrates that BSYJF attenuates KOA progression by regulating the ERα/PI3K/AKT signaling pathway. This multi-targeted action ameliorates cartilage degradation and aberrant bone remodeling, positioning BSYJF as a comprehensive therapeutic agent for KOA.

01 Aug 2026·JOURNAL OF ONCOLOGY PHARMACY PRACTICE

Initial real-world experience with ribociclib in advanced breast cancer

Article

Author: Zekri, Jamal ; Ibrahim, Refaei ; Rasool, Haleem ; Nawaz, Azhar

Purpose:

CDK4/6 inhibitors, such as ribociclib, are recommended in combination with hormonal therapy to treat advanced/metastatic hormone receptor-positive, HER2-negative breast cancer. The objectives of this study are to evaluate the therapeutic outcome and tolerance of ribociclib in patients treated at our institution.

Methods:

The initial cohort of patients who received >1 cycle of ribociclib between December 2018 and March 2022 were included. Rates of adverse events (AEs) related dose reduction and discontinuation of ribociclib were used as a surrogate marker for intolerance.

Results:

Sixty-eight female patients were included. Ribociclib was administered with letrozole or fulvestrant in the first-, second-, third-, and fourth-line palliative hormonal therapy settings in 29 (42.6%), 26 (38.2%), 12 (17.6%) and 1 (1.5%) patients respectively. Adverse events (AEs) related dose reduction was reported in 30 (44%) patients. Ribociclib was permanently discontinued in 42/68 (61.8%) patients [Disease progression 33/68 (48.5%) and AEs 9 (13.2%)]. Objective response was documented in 10/61 (16.4%) evaluable patients. The median progression free survival (PFS) was 18 months (95% CI: 11.7–24.3). The median overall survival (OS) was not reached and 84% of patients were alive at 3 years.

Conclusions:

Although objective response rates were modest in this mixed cohort of heavily pretreated patients, ribociclib combined with letrozole or fulvestrant has shown robust PFS and OS in real-world practice. AEs related treatment discontinuation rate is higher than that reported in clinical trials with stringent inclusion criteria.

852

News (Medical) associated with Fulvestrant

30 Jul 2026

·www.biospace.com

Newly FDA-Approved REVTORPYK™ (gedatolisib) Included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for HR+/HER2- Locally Advanced or Metastatic Breast Cancer

REVTORPYK (gedatolisib) in combination with fulvestrant, with or without palbociclib, listed as a preferred Category 1 regimen for second-line or subsequent treatment for tumors without a PIK3CA mutation following progression on or after at least one line of endocrine therapy MINNEAPOLIS, July 30, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced that REVTORPYK™ (gedatolisib) in combination with fulvestrant, with or without palbociclib, is recommended by the National Comprehensive Cancer Network ® (NCCN ® ) Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) as a preferred Category 1 second-line and/or subsequent-line therapy following progression on or after treatment with at least one line of endocrine therapy. REVTORPYK was granted approval by the U.S. Food and Drug Administration (“FDA”) on July 14, 2026, for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK is the only inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval. “The inclusion of REVTORPYK in the NCCN Guidelines shortly after FDA approval highlights the clinical relevance of this treatment option for patients with advanced breast cancer,” said Igor Gorbachevsky, Chief Medical Officer of Celcuity. “Because the NCCN Guidelines are a foundational resource for oncologists in determining the best course of treatment for patients, we believe these guidelines will increase awareness of REVTORPYK and support informed treatment decision-making for patients with HR+/HER2- locally advanced or metastatic breast cancer.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The approval of REVTORPYK is based on positive clinical results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, an open-label, global, randomized clinical trial evaluating the efficacy and safety of REVTORPYK plus fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- locally advanced or metastatic breast cancer following progression on or after CDK4/6 therapy and an aromatase inhibitor. In the VIKTORIA-1 trial, median progression free survival (“PFS”) with the REVTORPYK triplet (REVTORPYK plus palbociclib and fulvestrant) was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate (“ORR”) of the REVTORPYK triplet was 32% compared to 1% with fulvestrant, and the median duration of response (“DOR”) was 17.5 months. For the REVTORPYK doublet (REVTORPYK plus fulvestrant), the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). The ORR of the REVTORPYK doublet was 28%, and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response. See the following link for additional safety information and full prescribing information: The NCCN Guidelines ® play a pivotal role in decision-making processes for individuals involved in cancer care all over the world, including physicians, nurses, pharmacists, payers, and patients and their families. The guidelines present expert recommendations for cancer screening, diagnosis, and treatment, as well as cancer care options, and are utilized in cancer treatment decision-making to drive positive patient outcomes. NCCN is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to defining and advancing effective, equitable, accessible, and quality cancer care and prevention so all people can live better lives. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. Based on the company’s commitment to ensuring broad patient access to REVTORPYK, Celcuity has created a comprehensive patient support program. REVTORPYK is expected to be commercially available in the U.S. in the late third quarter of 2026. To make REVTORPYK available to patients prior to commercial launch, those who are eligible will be able to enroll in Celcuity’s expanded access program. Physician requests for participation in Celcuity’s expanded access program may be made by emailing: gedatolisib@tannerpharma.com . About REVTORPYK (gedatolisib) REVTORPYK is a kinase inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2, resulting in downstream inhibition of multiple effectors, including AKT. 3.4.5 REVTORPYK is in development for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer and for the second-line treatment of metastatic castration-resistant prostate cancer. Indication Statement REVTORPYK (gedatolisib) is a kinase inhibitor indicated in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Stomatitis: REVTORPYK can cause severe stomatitis, including ulcers and oral mucositis. Stomatitis occurred in 72% of patients treated with REVTORPYK with fulvestrant and palbociclib, including Grade 3 events in 22% of patients. Stomatitis occurred in 58% of patients treated with REVTORPYK with fulvestrant, including Grade 3 events in 12% of patients. Initiate a steroid-containing, alcohol-free mouthwash prior to starting treatment with REVTORPYK and continue prophylactically during treatment. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity. Dermatologic Adverse Reactions: REVTORPYK can cause severe rash. Rash occurred in 30% of patients treated with REVTORPYK in combination with fulvestrant and palbociclib, including Grade 3 events in 6% of patients. Rash occurred in 40% of patients treated with REVTORPYK with fulvestrant, including 5% of patients with Grade 3 events. Monitor patients for rash and infectious sequelae. Instruct patients to limit sun exposure during REVTORPYK treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity. Hyperglycemia: REVTORPYK can cause severe hyperglycemia. Monitor fasting glucose prior to initiating treatment with REVTORPYK and periodically during treatment. Monitor HbA1c level if clinically indicated. Increased fasting glucose occurred in 46% of patients receiving REVTORPYK in combination with fulvestrant and palbociclib (Grade 3: 0.9%) and in 57% of patients receiving REVTORPYK in combination with fulvestrant (Grade 3: 1.8%). The safety of REVTORPYK has not been established in patients with Type 1 or uncontrolled Type 2 diabetes mellitus. Patients with well-controlled Type 2 diabetes may require intensified antihyperglycemic therapy and close monitoring of fasting glucose. Manage hyperglycemia with antihyperglycemic medications as clinically indicated. Evaluate fasting blood glucose and HbA1c levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue REVTORPYK based on severity. Embryo-Fetal Toxicity: Based on its mechanism of action, REVTORPYK can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with REVTORPYK and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose. Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When REVTORPYK is used in combination, advise patients to use effective contraception during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Verify the pregnancy status of females of reproductive potential prior to initiating treatment. ADVERSE REACTIONS REVTORPYK in Combination with Fulvestrant and Palbociclib: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant and palbociclib were decreased white blood cells, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, stomatitis, nausea, decreased platelets, increased fasting glucose, fatigue, vomiting, rash, constipation, diarrhea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), musculoskeletal pain, decreased sodium, and increased eosinophils. REVTORPYK in Combination with Fulvestrant: The most common (≥20%) adverse reactions, including laboratory abnormalities when given in combination with fulvestrant were stomatitis, glucose increased, eosinophils increased, hemoglobin decreased, nausea, rash, ALT increased, fatigue, musculoskeletal pain, lymphocytes decreased, vomiting, AST increased, pruritus, and diarrhea. USE IN SPECIFIC POPULATION Lactation: Advise women not to breastfeed during treatment with REVTORPYK and for 2 weeks after the last dose. When used in combination, advise patients not to breastfeed during treatment and for the longest post-treatment duration recommended in the Prescribing Information of any of the individual products. Infertility: Advise females and males of reproductive potential that REVTORPYK may impair fertility. Please see full Prescribing Information , including Patient Information , for REVTORPYK. You may report side effects related to Celcuity products to Celcuity Medical Information at 1-877-4-CELCUITY (1-877-423-5284) or to FDA at 1-800-FDA-1088 or . © 2026 Celcuity Inc. All rights reserved. REVTORPYK and its logo are trademarks of Celcuity, Inc. US-G1B-26-023407/26 About Celcuity Celcuity is a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast cancer (“ABC”), supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected. Results for the PIK3CA mutant cohort of VIKTORIA-1 have been released. VIKTORIA-2 is an ongoing Phase 3 clinical trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib plus fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib plus letrozole as first-line treatment for patients with endocrine- sensitive HR+/HER2- ABC. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov . Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at . Follow us on LinkedIn and X . Forward Looking Statements This press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of the Company’s clinical trials; the Company’s interpretation of clinical trial data; the Company’s expectations regarding the timing of and its ability to commercialize gedatolisib; the Company’s strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib; the Company’s anticipated use of cash; and the strength of its balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that the Company’s topline clinical results are based on an ongoing analysis of efficacy and safety data and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in the Company’s clinical trials or the submission, and FDA’s review of, its supplemental new drug application (“sNDA”) for gedatolisib; the Company’s ability to obtain regulatory approval of its sNDA and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; the development of therapies and tools competitive with gedatolisib; and the Company’s ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in its subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. Contacts: For Investors: Brian Sullivan, bsullivan@celcuity.com Vicky Hahne, vhahne@celcuity.com (763) 392-0123 Jodi Sievers, jsievers@celcuity.com (415) 494-9924 For Media: Sam Brown LLC Laura Morgan, lauramorgan@sambrown.com (951) 333-9110

Phase 3Clinical ResultDrug ApprovalNDA

24 Jul 2026

·www.astrazeneca.com

Enhertu plus pertuzumab recommended for approval in the EU by CHMP as 1st-line treatment for patients with HER2-positive metastatic breast cancer

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast09 Phase III trial presented at the 2025 American Society of Clinical Oncology Annual Meeting and subsequently published in The New England Journal of Medicine.1 Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “HER2-positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2-targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes. DESTINY-Breast09 sets a new benchmark with a median progression-free survival of more than three years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2-positive metastatic breast cancer.” John Tsai, Global Head, R&D, Daiichi Sankyo, said: “Enhertu in combination with pertuzumab improved progression-free survival by more than one year compared with the current first-line standard of care, representing a meaningful advantage early in the treatment of patients with metastatic HER2-positive disease. Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2-positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway.” In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (based on a hazard ratio of 0.56; 95% confidence interval [CI]: 0.44-0.71; p<0.00001) in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Median progression-free survival (PFS) was 40.7 months with Enhertu in combination with pertuzumab compared to 26.9 months with THP. The PFS benefit was consistent across subgroups, including for the prespecified stratification factorsof hormone receptor status, de novo or recurrent disease and PIK3CA mutation status. The safety profile of Enhertu plus pertuzumab was consistent with the known profiles of each individual therapy with no new safety concerns identified. Enhertu in combination with pertuzumab is approved in the US, Switzerland and other countries as a 1st-line treatment for patients with metastatic HER2-positive breast cancer based on the results from the DESTINY-Breast09 trial. Enhertu is also under review in the EU for patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment based on data from the DESTINY-Breast05 trial. Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Notes HER2-positive metastatic breast cancer Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related death among women.2 Approximately, 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.2 In Europe, approximately 540,000 cases of breast cancer are diagnosed annually, with more than 140,000 deaths.3 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or whose disease has progressed to metastatic disease are expected to live five years following diagnosis.4 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.5 HER2 protein overexpression may occur as a result of HER2 gene amplification.4 Approximately one in five cases of breast cancer is considered HER2-positive.5 HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.6 While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.6-8 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.10,11 DESTINY-Breast09 DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status. The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, ORR, duration of response, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis. DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov. Enhertu Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4mg/kg) followed by THP is approved in the US, China and Singapore as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (5.4mg/kg) is approved in the US as an adjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US, Switzerland, India, Israel, United Arab Emirates, Saudi Arabia, Korea and Singapore as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on the results from the DESTINY-Breast09 trial. Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally authorised test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials. Enhertu (5.4mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu clinical development programme A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and expanding its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD, Etcamah. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with Etcamah in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Oncology Corporate and financial

Clinical ResultDrug ApprovalPhase 3License out/inASCO

23 Jul 2026

·www.astrazeneca.com

Etcamah (camizestrant) in combination with a CDK4/6 inhibitor approved in the EU for 1st-line advanced ER-positive breast cancer

AstraZeneca’s Etcamah (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) has been approved in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of ESR1 mutation and without disease progression during 1st-line endocrine therapy in combination with a CDK4/6 inhibitor. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on the positive results from the pivotal SERENA-6 Phase III trial published in The New England Journal of Medicine.1 In a planned interim analysis, the Etcamah combination reduced the risk of disease progression or death by 56% versus standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (based on a hazard ratio [HR] of 0.44; 95% confidence interval [CI]:0.31-0.60; p<0.00001; median progression-free survival (PFS) 16.0 versus 9.2 months). In Europe, breast cancer remains the leading cause of cancer death among women, with more than 140,000 deaths in 2024 and more than 540,000 patients diagnosed in the same year.2 Hormone receptor (HR)-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative.3 More than 97% of HR-positive breast cancer tumours are ER-positive.4,5 Across the UK, France, Germany, Spain and Italy, approximately 37,000 patients with HR-positive metastatic breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies paired with CDK4/6 inhibitors.6-8 However, many patients have tumours that develop resistance to these therapies, at which point treatment options are limited and survival rates are low, with only approximately 36% of patients anticipated to live beyond five years after diagnosis.3,8 Mutations in the ESR1 gene are a key driver of endocrine resistance and are associated with poor outcomes, emerging during treatment of the disease and becoming more prevalent as the disease progresses.9,10 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment before disease progression.6 François-Clément Bidard MD, PhD, Professor of Medical Oncology at Institut Curie & Versailles University (Paris/Saclay) France and co-principal investigator for the trial, said: “Today’s approval is welcome news for the one in three patients in Europe with this form of advanced breast cancer whose tumours develop ESR1 mutations before disease progression and are in urgent need of new options that both delay this progression and extend the benefit of 1st-line treatments. As the first pivotal trial to demonstrate the clinical value of monitoring circulating tumour DNA in the 1st-line breast cancer setting, SERENA-6 represents a significant advance in clinical practice and it is now important to identify patients who may be able to benefit from this combination and intervene promptly before their disease progresses.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “The approval of the Etcamah combination marks an important shift in the 1st-line treatment paradigm for patients with ER-positive, HER2-negative advanced breast cancer in Europe, providing a new standard-of-care to address emerging resistance ahead of disease progression. It also reflects the strength of AstraZeneca’s oncology pipeline and our commitment to translate innovative science into practice-changing treatment options for patients.” Data for the key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of the interim analysis of the SERENA-6 trial, however, a subsequent pre-planned analysis demonstrated a statistically significant and clinically meaningful PFS2 benefit of 25.7 months versus 19.1 months in favour of the Etcamah combination (HR: 0.63; 95% CI: 0.46-0.86; p=0.00373) and OS continued to mature in favour of the Etcamah combination (HR: 0.87; 95% CI: 0.57-1.30). The trial will continue to assess OS as a key secondary endpoint. The safety profile of Etcamah in combination with palbociclib, ribociclib or abemaciclib in the SERENA-6 trial was consistent with the known safety profile of each medicine. No new safety concerns were identified, and discontinuations were very low and similar in both arms.1 SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The innovative trial design used ctDNA monitoring via a blood test at the time of routine tumour scans every two to three months to identify patients for early signs of endocrine resistance via the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to Etcamah from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor. Etcamah is also approved in Japan, the United Arab Emirates and Saudi Arabia based on the SERENA-6 Phase III trial. Regulatory applications for Etcamah in this setting are currently under review in several other countries including the US where the US Food and Drug Administration recently extended the Prescription Drug User Fee Act date to review the updated results from the trial. Notes HR-positive breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.11 More than two million patients were diagnosed with breast cancer in 2024, with more than 690,000 deaths globally.11 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.3 Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target ER-driven disease, which are often paired with CDK4/6 inhibitors.6-8 The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research.  SERENA-6 SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation. The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment. Etcamah Etcamah (camizestrant) is a potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist, administered orally, once daily. The recommended dose of Etcamah in combination with a CDK4/6 inhibitor is 75mg. Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) is approved in the EU, Japan and several other countries for the treatment of adult patients with HR-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer upon detection or emergence of ESR1 mutation and without disease progression during 1st-line endocrine therapy based on the results from the SERENA-6 trial. The broad, robust and innovative Etcamah clinical development programme, including the SERENA-4, CAMBRIA-1 and CAMBRIA-2 Phase III trials, is evaluating the safety and efficacy of Etcamah when used as a monotherapy or in combination with CDK4/6 inhibitors to address a number of areas of unmet need in HR-positive, HER2-negative breast cancer. Etcamah has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated a statistically significant and clinically meaningful improvement in PFS versus Faslodex (fulvestrant) in the overall trial population, including in patients with ESR1 tumour mutations irrespective of prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors. AstraZeneca in breast cancer  Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD, Etcamah. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with Etcamah in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). AstraZeneca in oncology  AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.  The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.  AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

Clinical ResultPhase 3Phase 1Drug ApprovalImmunotherapy

100 Deals associated with Fulvestrant

External Link

KEGG	Wiki	ATC	Drug Bank
D01161	Fulvestrant	L02BA03	DB00947

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced breast cancer	Brazil	Libbs Farmacêutica Ltda.	25 Jun 2018
Metastatic breast cancer	Brazil	Libbs Farmacêutica Ltda.	25 Jun 2018
Hormone Receptor Positive Breast Adenocarcinoma	United States	AstraZeneca Pharmaceuticals LP	25 Aug 2017
Breast Cancer	Japan	AstraZeneca KK	26 Sep 2011
Estrogen receptor positive breast cancer	European Union	AstraZeneca AB	09 Mar 2004
Estrogen receptor positive breast cancer	Iceland	AstraZeneca AB	09 Mar 2004
Estrogen receptor positive breast cancer	Liechtenstein	AstraZeneca AB	09 Mar 2004
Estrogen receptor positive breast cancer	Norway	AstraZeneca AB	09 Mar 2004
Hormone receptor positive HER2 negative breast cancer	European Union	AstraZeneca AB	09 Mar 2004
Hormone receptor positive HER2 negative breast cancer	Iceland	AstraZeneca AB	09 Mar 2004
Hormone receptor positive HER2 negative breast cancer	Liechtenstein	AstraZeneca AB	09 Mar 2004
Hormone receptor positive HER2 negative breast cancer	Norway	AstraZeneca AB	09 Mar 2004
Hormone receptor positive breast cancer	United States	AstraZeneca Pharmaceuticals LP	25 Apr 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Unresectable Breast Carcinoma	Phase 3	-	Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.	10 Feb 2026
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	-	Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.	10 Feb 2026
Neoplasm Metastasis	Phase 3	United States	Eli Lilly & Co.	11 Mar 2022
Neoplasm Metastasis	Phase 3	Argentina	Eli Lilly & Co.	11 Mar 2022
Neoplasm Metastasis	Phase 3	Belgium	Eli Lilly & Co.	11 Mar 2022
Neoplasm Metastasis	Phase 3	Czechia	Eli Lilly & Co.	11 Mar 2022
Neoplasm Metastasis	Phase 3	Denmark	Eli Lilly & Co.	11 Mar 2022
Neoplasm Metastasis	Phase 3	France	Eli Lilly & Co.	11 Mar 2022
Neoplasm Metastasis	Phase 3	Greece	Eli Lilly & Co.	11 Mar 2022
Neoplasm Metastasis	Phase 3	Hungary	Eli Lilly & Co.	11 Mar 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03439046 (BioItaLEE \| Phase IIIb, CTgov)	Phase 3	Leukodystrophy, Hypomyelinating, 6 \| Breast Cancer \| Locally advanced breast cancer ... View more	287	Letrozole+Ribociclib (Ribociclib+Letrozole (Core Phase))	xrjocwxxqe(gqywtxbbbi) = uobqmyzjmz iffscaqfpr (atdnxnwfjy, uarjkjncky - gpyxqicxim) View more	-	10 Jul 2026
				Fulvestrant+Alpelisib (Alpelisib+Fulvestrant (Extension Phase))	ornwvmpxst = gwkjsaqviw kmieioqxqy (pbbbudhzue, hqvpizujii - bzefykzbzw) View more
NCT05631795 (ALPINIST, CTgov)	Phase 4	HR Positive/HER2 Negative/Node positive breast cancer \| Advanced breast cancer	40	fulvestrant+Alpelisib	teidmeldhn = hypezihedm vbbjhhtjys (mozyunugvv, gnphojxeca - jxgkgledrx) View more	-	25 Jun 2026
NCT04263298 (ChiCTR-IIR-17014036, Pubmed \| Signal Transduct Target Ther)	Phase 3	Hormone receptor positive HER2 negative breast cancer Maintenance HR+ \| HER2-	210	Fulvestrant	eauxhnnwyu(cmuhevnbzv) = jtvlngbcly ppusbwqnzj (rbzrlsuqwp, 12.7 - 23.3) View more	Positive	22 May 2026
				Capecitabine	eauxhnnwyu(cmuhevnbzv) = oabqvddhdq ppusbwqnzj (rbzrlsuqwp, 7.5 - 14.3) View more
EUCTR2016-002893-11-SE (PASIPHAE, ESMO_BC2026)	Phase 2	Hormone receptor positive HER2 negative breast cancer First line HR+/HER2-	41	Capecitabine	jvpwndjefw(ngljpcxrtz) = bmifwbgkwb xgpohpzppt (tcpkhgmybx ) View more	Positive	07 May 2026
				Fulvestrant/ Palbociclib	jvpwndjefw(ngljpcxrtz) = pavhwoinld xgpohpzppt (tcpkhgmybx ) View more
NCT07333937 (ESMO_BC2026)	Phase 2	Advanced breast cancer HR+ \| HER2+	35	Neratinib + Eribulin + Fulvestrant	vnxeyuhzqu(iwnqibgzep) = The most common treatment-related AEs (TRAEs) were diarrhea (97.1%, all grade; 64.3% grade ≥3), fatigue (62.9%, all grade; 35.7% grade ≥3), and nausea (62.9%, all grade; 17.9% grade ≥3). zxzbjbfffw (mpvlpplbds )	Positive	07 May 2026
NCT06105632 (FOURLIGHT-1, Company_Website) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer Second line HER2 Negative \| HR Positive	264	Atirmociclib + Fulvestrant	ydufcctwdq(eqctwuyotm): HR = 0.6 (95.0% CI, 0.44 - 0.825), P-Value = 0.0007 Met View more	Positive	17 Mar 2026
				fulvestrant+exemestane or everolimus + exemestane
NCT05554354 (CTgov)	Phase 2	Hormone receptor positive breast cancer \| Hormone Receptor Positive Breast Adenocarcinoma \| Metastatic breast cancer ... View more	1	Multigated Acquisition Scan+fulvestrant+Binimetinib (Cohort I (Arm I) (Fulvestrant, Binimetinib))	svruzyvutt(lghvmaqyyv) = whdwajcsmm ozpooswwsu (xlajtlatww, wtcxczuhgn - cfyimguovy) View more	-	03 Mar 2026
				Multigated Acquisition Scan+fulvestrant (Cohort I (Arm II))	svruzyvutt(lghvmaqyyv) = ohyhznttrt ozpooswwsu (xlajtlatww, tguhmyrrik - tslfbijpqu) View more
NCT05101564 (CTgov)	Phase 2	ER-positive/HER2-negative Breast Cancer \| HER2-negative breast cancer \| Estrogen receptor positive breast cancer	19	Fulvestrant+Zotatifin (Cohort 2: Zotatifin in Combination With Fulvestrant (Treatment Arm))	zyrxqtffbz(dclxvegtbn) = atgfsahvli udpevdbzko (hvanuafsce, uaywkuwgwh - urlghuekws) View more	-	22 Jan 2026
				Fulvestrant (Cohort 2: Fulvestrant (Control Arm))	zyrxqtffbz(dclxvegtbn) = iilqzwkode udpevdbzko (hvanuafsce, vlizozinhi - lugrcvgwru) View more
SABCS2025	Phase 2	HR-positive \| HER2-negative	30	Chidamide + Fulvestrant	xgazqcerwb(ljcggcpcvy) = eioccevddz wcxpmrhcwg (iumuyqbzcu )	Positive	10 Dec 2025
ESMO_ASIA2025	Not Applicable	ER-positive/HER2-negative Breast Cancer Neoadjuvant HER2-negative \| ER+/PR+	34	Fulvestrant+Triptorelin+Ribociclib	xszzuoolkr(vtcjwkcfnk) = wmzpuwfyxe ipfbsoqbxy (yegvntxbqj ) View more	Positive	05 Dec 2025

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis