RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Special Review Project (China), Priority Review (Australia), Accelerated assessment (European Union), Priority Review (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC29H37N7O5S

InChIKeyFUKSNUHSJBTCFJ-UHFFFAOYSA-N

CAS Registry1421373-66-1

368

Clinical Trials associated with Osimertinib mesylate

NCT07153055

/ Not yet recruitingPhase 1/2IIT

Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).

Start Date01 May 2026

Sponsor / Collaborator

Indiana University

[+1]

NCT07295821

/ Not yet recruitingPhase 2

Phase II, Single-arm Multicenter Study of Osimertinib Induction Before Radiotherapy and Maintenance in Chemo-ineligible or Refusing Patients With Stage III, Unresectable NSCLC and EGFR Mutation-positive Tumors

The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).

Start Date09 Mar 2026

Sponsor / Collaborator

AstraZeneca PLC

NCT07279935

/ Not yet recruitingPhase 4

Biomarker-Directed Treatment in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC: A Prospective, Multi-cohort, Interventional Study (REVIVE)

This study is designed as a multi-cohort trial based on various patient biomarkers study with the potential to include new study treatment in the future. EGFR-sensitive mutation-positive patients with distant recurrence after adjuvant osimertinib treatment for EGFRm resectable SIB-IIIA NSCLC and scheduled to receive osimertinib plus chemotherapy will be enrolled in cohort 1. In this cohort, approximately 100 patients will be recruited from 25 sites in China. The enrolment period is planned to be approximately 16 months.

Start Date15 Jan 2026

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Osimertinib mesylate

100 Translational Medicine associated with Osimertinib mesylate

100 Patents (Medical) associated with Osimertinib mesylate

4,279

Literatures (Medical) associated with Osimertinib mesylate

01 Jan 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery of a brain-penetrant fourth-generation EGFR inhibitor to overcome the human triple (L858R/T790 M/C797S) mutation

Article

Author: Zhao, Lei ; Xie, Peng ; Shi, Jia Chen ; Wang, Guan ; Zhong, Yi Sheng

Brain metastasis remains a major challenge in lung cancer treatment because most small-molecule targeted therapies are severely limited in their efficacy against brain metastasis by efflux transporters on the blood-brain barrier (BBB). Osimertinib has been approved as the first-line treatment for EGFR-mutated non-small cell lung cancer (NSCLC) and exhibits good brain penetration. However, clinical resistance to Osimertinib mediated by the tertiary C797S mutation remains an unmet medical need. Here, we report a series of brigatinib derivatives, rationally designed as fourth-generation EGFR inhibitors. The representative compound D18 exhibits potent inhibitory activity against EGFR^{L858R/T790M/C797S}, with an IC₅₀ of 1.32 nM, and significantly inhibits the proliferation of the NCI-H1975 cell line harboring EGFR^{L858R/T790M/C797S}, with an IC₅₀ of 0.87 μM. In addition, compound D18 exhibits a favorable pharmacokinetic profile and excellent BBB permeability. It significantly inhibits tumor growth in the NCI-H1975 xenograft tumor model. Based on its excellent in vitro and in vivo properties, compound D18 can be considered a promising candidate for the treatment of EGFR ^{L858R/T790M/C797S} triple mutations and brain metastases.

31 Dec 2025·ANNALS OF MEDICINE

Comparison of first-generation EGFR-TKIs combined with low-dose bevacizumab versus osimertinib in untreated advanced EGFR-mutated NSCLC

Article

Author: Xu, Yingqi ; Zhong, Runbo ; Jin, Hongping ; Lou, Yuqing ; Zhong, Hua ; Zhang, Yidan ; Xu, Jianlin

BACKGROUND:

This study aimed to compare the efficacy of first-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) combined with low-dose bevacizumab(7.5 mg/kg) versus osimertinib as first-line treatment in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC).

MATERIALS AND METHODS:

A total of 161 patients with advanced NSCLC harboring EGFR mutations, who received first-line treatment at Shanghai Chest Hospital between July 2017 and July 2023, were enrolled in this study. Among them, 78 patients were treated with a combination of first-generation EGFR-TKIs and bevacizumab (7.5 mg/kg), constituting the bevacizumab plus TKI (A + T) group. The remaining 83 patients received osimertinib monotherapy (80 mg daily), forming the osimertinib group.

RESULTS:

The objective response rate (ORR) was 65.4% (51/78) in the A + T group and 68.7% (57/83) in the osimertinib group (p = 0.657). Despite the potentially poorer baseline conditions of patients in the osimertinib group, the median progression-free survival (PFS) was 16.59 months (95% CI: 14.39-18.80) in the A + T group compared to 16.82 months (95% CI: 13.76-19.89) in the osimertinib group (p = 0.792). Preliminary overall survival (OS) analysis indicated a median OS of 51.75 months (95% CI: 41.63-61.86) in the A + T group versus 35.55 months (95% CI: 22.32-48.77) in the osimertinib group (p = 0.010), however, the OS data are not yet mature.

CONCLUSION:

Although osimertinib remains the preferred first-line treatment for advanced NSCLC with EGFR mutations, combining first-generation EGFR-TKIs with low-dose bevacizumab may be a viable alternative for certain patients.

01 Dec 2025·BIOCHEMICAL PHARMACOLOGY

Targeting N6-methyladenosine demethylase FTO overcomes osimertinib resistance by inducing G0/G1 phase arrest in an m6A-dependent manner in lung adenocarcinoma

Article

Author: Zhao, Yun ; Zhu, Yong ; Liang, Zhanwen ; Huang, Haitao ; Wu, Jing ; Chen, Jun ; Qian, Jing ; Li, Yan ; Chen, Chao ; Hu, Chengru

Resistance to osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), is a significant challenge for patients with advanced EGFR-mutant lung adenocarcinoma (LUAD). Fat mass and obesity-associated protein (FTO), an N⁶-methyladenosine (m⁶A) demethylase, plays a critical role in the occurrence, metastasis, and drug resistance of various tumors. We found that high FTO expression was significantly associated with resistance to osimertinib in advanced LUAD patients harboring EGFR mutations. In vitro experiments indicated that FTO enhanced the resistance of LUAD cells to osimertinib by reducing m⁶A modification. FTO silencing induced G0/G1 phase arrest in resistant cells in an m⁶A-dependent manner, restoring osimertinib sensitivity. Both in vivo and in vitro studies showed that FB23-2, an FTO inhibitor, synergistically suppressed the growth of resistant cells in combination with osimertinib. Furthermore, LUAD patient-derived organoids maintained histological and genetic consistency with patient tissues, where FTO was highly expressed in osimertinib-resistant organoids. The combination of FB23-2 and osimertinib effectively inhibited the growth of osimertinib-resistant organoids. Overall, this study demonstrates that FTO promotes osimertinib resistance and targeting FTO induces G0/G1 arrest in an m⁶A-dependent manner. The combination of FTO inhibitor and osimertinib provides a strategy to override osimertinib resistance.

875

News (Medical) associated with Osimertinib mesylate

27 Dec 2025

·www.globenewswire.com

ArriVent Announces First Patient Dosed in Global Pivotal Phase 3 ALPACCA Trial Evaluating Firmonertinib for First-Line Treatment of EGFR PACC Mutant Non-Small Cell Lung Cancer

Firmonertinib has the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals Dec. 22, 2025 -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the first patient has been dosed in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of EGFR PACC mutant non-small cell lung cancer (NSCLC). Firmonertinib is an oral, once daily, highly brain-penetrant and broadly active mutation-selective EGFR inhibitor. “Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib,” said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. “Patients with EGFR PACC mutant NSCLC currently have limited treatment options and represent a clear unmet medical need. With a well-characterized safety profile and broad clinical systemic and central nervous system (CNS) activity in patients, we believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations and the potential to become a cornerstone therapy across the EGFR mutant spectrum.” PACC mutations represent a distinct and underserved population of EGFR mutant NSCLC, with limited approved first-line targeted therapies and historically poor outcomes. The ALPACCA (FURMO-006) randomized, global Phase 3 study is evaluating firmonertinib 240 mg once daily versus investigator’s choice of osimertinib or afatinib in first-line patients with EGFR PACC mutant NSCLC. The primary endpoints are overall response rate (ORR) and progression-free survival (PFS) by blinded independent central review (BICR). The 240 mg dose of firmonertinib was selected for pivotal development based on compelling data showing a 16-month median PFS and a confirmed 68% ORR by BICR in the FURTHER trial. The ALPACCA study is designed to support potential global registration with endpoints for accelerated and full approval pathways. We estimate that the global ex-China annual incidence of NSCLC patients with EGFR PACC mutations to be approximately 42,000 patients and the US annual incidence to be approximately 6,200 patients. ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization. Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations. Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations. Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA). Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. Mutational activation of the EGFR is a frequent and early event in the development of NSCLC. EGFR mutations are divided into classical and uncommon. EGFR exon 20 insertion mutations are a group of uncommon EGFR mutations and constitute approximately 9% of all EGFR mutations. PACC mutations are another group of uncommon EGFR mutations and represent approximately 12% of all EGFR mutations. Patients with NSCLC whose tumors harbor uncommon EGFR mutations have significantly lower life expectancy with available therapies and represent an area of unmet medical need. P-loop and αC-helix compressing (PACC) EGFR mutations are a distinct set of approximately 70 mostly missense activating mutations within the kinase domain of EGFR. They are similar to Exon 20 insertion mutations in narrowing the drug binding pocket to affect tyrosine kinase inhibitor activity. PACC mutations are diagnosed through commercially available NGS and most PCR tests. Patients with PACC mutations have limited treatment options, and there is no broadly utilized standard of care treatment for first-line PACC mutant patients. FURVENT is a global, pivotal, 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Secondary endpoints in patients with brain metastases at baseline include brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China. An interim analysis for this study has not been performed and there is no plan to perform such analysis given the expected timing of top-line data. The content above comes from the network. if any infringement, please contact us to modify.

Orphan DrugBreakthrough TherapyClinical ResultDrug Approval

18 Dec 2025

·www.fiercepharma.com

J&J scores FDA nod for subcutaneous lung cancer shot, sharpening its challenge to Tagrisso

Johnson & Johnson's Rybrevant-Lazcluze combo has beat Tagrisso on efficacy, reducing patients’ risk of death by 25% for the first-line treatment of EGFR-mutated non-small cell lung cancer. A year after an FDA rejection, Johnson & Johnson has won approval for a more convenient version of its lung cancer drug Rybrevant to better challenge AstraZeneca’s Tagrisso.Rybrevant Faspro, a subcutaneous formulation of Rybrevant, is now cleared in the same indications as the original intravenous infusion, including its use alongside J&J’s Lazcluze for the first-line treatment of EGFR-mutated metastatic non-small cell lung cancer (NSCLC).Compared with the original Rybrevant, the under-the-skin version reduces the antibody drug’s administration time from several hours to about five minutes, which J&J suggests is more convenient for patients and less burdensome for healthcare resources.“This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment,” Joelle Fathi, chief healthcare delivery officer at GO2 for Lung Cancer, a patient support group, said in a Dec. 17 statement.The approval arrives a year after FDA inspection findings at a manufacturing facility led to a complete response letter for subcutaneous Rybrevant, which was developed using Halozyme Therapeutics’ Enhanze drug delivery technology.J&J hopes the latest Faspro offering can repeat the success of the company’s blockbuster multiple myeloma drug Darzalex Faspro. But, unlike the almost-unchallenged anti-CD38 drug, Rybrevant faces an uphill fight against AZ’s Tagrisso and the dominant EGFR inhibitor’s latest combination with chemotherapy.J&J’s Rybrevant-Lazcluze combo already beat Tagrisso on efficacy, reducing patients’ risk of death by 25% in the phase 3 Mariposa trial in first-line EGFR-mutated NSCLC. But Tagrisso’s convenience as a once-daily tablet and its well-understood safety profile could still make persuading doctors to switch to Rybrevant-Lazcluze an arduous process for J&J. On the safety side, Rybrevant Faspro is an improvement from infused Rybrevant, thanks to its ability to reduce the rate of administration-related reactions to 13% from 66%, according to results from the phase 3 Paloma-3 trial. The study compared the two versions of amivantamab in their separate combinations with Lazcluze in previously treated EGFR-mutated NSCLC.Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, was also lower, at 11%, for the combo with subcutaneous Rybrevant, versus 18% observed in patients who received the intravenous formulation in Paloma-3.But VTE could be an Achilles’ heel of J&J’s Rybrevant regimen in its ongoing battle against Tagrisso. In the Mariposa trial in the first-line setting, intravenous Rybrevant and Lacluze were linked to a 36% VTE rate, whereas only 9% of Tagrisso takers experienced VTE. As a result, prophylactic anticoagulation is recommended for the first four months of treatment with Rybrevant or Rybrevant Faspro.To prop up Tagrisso’s efficacy, AZ last year won the FDA’s approval for its use alongside chemotherapy after the phase 3 Flaura2 trial showed that the combo reduced the risk of disease progression or death by 38% compared with Tagrisso alone. Then, earlier this year, AZ reported that the trial met its overall survival endpoint, with the combo boasting a 23% death risk reduction versus Tagrisso monotherapy.J&J has argued that patients do not want to take chemotherapy upfront given its toxicity. Now, with Rybrevant Faspro, the administration time of the J&J regimen is also shorter than chemo, which the company said could take up to an hour. Rybrevant Faspro may also hold an efficacy advantage over the original Rybrevant. In the Paloma-3 trial, the two formulations showed similar pharmacokinetic results as measured by amivantamab levels in the blood. But overall survival data were surprisingly better for patients treated with Rybrevant Faspro, with a 38% death risk improvement.J&J has hypothesized that subcutaneous absorption of the drug may potentially enhance immune-mediated anticancer activity. This survival finding was drawn from the second-line setting, and it was not included in Rybrevant Faspro’s label.Before the latest nod, Rybrevant and Lazcluze together brought in $136 million in U.S. sales in the third quarter, versus $139 million in the second quarter and $113 million in the first.In the first nine months of 2025, Tagrisso increased sales by 11% year over year in the U.S., reaching $2.2 billion, as AZ touted the Flaura2 regimen as the leading combo in first-line EGFR-mutated NSCLC.

Phase 3Clinical ResultDrug ApprovalADC

18 Dec 2025

·www.prnewswire.com

U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with ENHANZE® for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer

RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) SAN DIEGO, Dec. 18, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE® for patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).1 RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) and represents the first and only subcutaneously (SC) administered targeted therapy for patients with EGFR+ mNSCLC. Compared to intravenous (IV) delivery, RYBREVANT FASPRO™ significantly reduced administration time from several hours to approximately five minutes and demonstrated an approximately fivefold reduction in administration-related reactions (ARRs) (13 percent in SC vs 66 percent in IV arm). "Formulated with our leading ENHANZE drug delivery technology, RYBREVANT FASPRO™ has the potential to make administration faster and more convenient for patients and their families compared to intravenous administration," said Dr. Helen Torley, president and chief executive officer of Halozyme. "By reducing administration times and simplifying the treatment experience, ENHANZE-formulated products could also support efficiencies for healthcare providers and lower costs for the healthcare system. This approval underscores ENHANZE's role in delivering meaningful clinical and economical value for patients, providers and payers." Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUCD1-D15)].1,2 For more information on this approval, please view Johnson & Johnson's press release issued on December 17, 2025. References 1.RYBREVANT FASPRO™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 2.Yang J et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line EGFR-mutant Advanced NSCLC – Final Overall Survival from MARIPOSA [ELCC abstract #40]. Presented at: 2025 European Lung Cancer Congress (ELCC); March 26-29, 2025; Paris, France. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, and Merus N.V. Halozyme is also developing Hypercon™ to expand the breadth of its drug delivery technology portfolio. Hypercon™ is an innovative microparticle technology that is expected to set a new standard in hyper concentration of drugs and biologics that can reduce the injection volume for the same dosage and expands opportunities for at-home and health care provider administration. The addition of Hypercon™ enhances our ability to transform the patient treatment experience by enabling the creation and delivery of highly concentrated biologics, substantially broadening the scope of therapeutics that can be delivered subcutaneously. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Johnson & Johnson, Eli Lilly, and argenx. Halozyme also develops, manufactures, and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability, and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products, and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility. For more information, visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and administration-related reactions, broadening the treatment options for the indications referred to in this press release, support efficiencies for healthcare providers and potentially lower healthcare system costs. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] SOURCE Halozyme Therapeutics, Inc. 21% more press release views with Request a Demo

Drug ApprovalClinical ResultPhase 3

100 Deals associated with Osimertinib mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D10766	Osimertinib mesylate	L01XE	DB09330

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Canada	AstraZeneca Canada, Inc.	05 Jul 2016
EGFR positive non-small cell lung cancer	Japan	AstraZeneca Pharmaceuticals Co. Ltd.	28 Mar 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	European Union	AstraZeneca AB	01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	Iceland	AstraZeneca AB	01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	Liechtenstein	AstraZeneca AB	01 Feb 2016
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	Norway	AstraZeneca AB	01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	European Union	AstraZeneca AB	01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	Iceland	AstraZeneca AB	01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	Liechtenstein	AstraZeneca AB	01 Feb 2016
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	Norway	AstraZeneca AB	01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer	European Union	AstraZeneca AB	01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer	Iceland	AstraZeneca AB	01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer	Liechtenstein	AstraZeneca AB	01 Feb 2016
EGFR-mutated non-small Cell Lung Cancer	Norway	AstraZeneca AB	01 Feb 2016
metastatic non-small cell lung cancer	European Union	AstraZeneca AB	01 Feb 2016
metastatic non-small cell lung cancer	Iceland	AstraZeneca AB	01 Feb 2016
metastatic non-small cell lung cancer	Liechtenstein	AstraZeneca AB	01 Feb 2016
metastatic non-small cell lung cancer	Norway	AstraZeneca AB	01 Feb 2016
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	United States	AstraZeneca Pharmaceuticals LP	13 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 3	China	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	France	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	Malaysia	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	Poland	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	South Korea	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	Taiwan Province	AstraZeneca PLC	08 May 2023
Neoplasms	Phase 3	United Kingdom	AstraZeneca PLC	08 May 2023
Carcinoma	Phase 3	United States	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	China	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Japan	AstraZeneca PLC	03 Aug 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03778229 (SAVANNAH, Pubmed \| Clin Lung Cancer)	Phase 2	MET gene amplification Non-small Cell Lung Cancer MET Amplified \| EGFR Mutated	30	Savolitinib 300 mg QD + Osimertinib 80 mg QD	yuxogzjjyt(emwnubtrua) = ahcqcumoaz leezqggqqw (ulsmoxzvnj, 29 - 82) View more	Positive	01 Jan 2026
				Savolitinib + Placebo	yuxogzjjyt(emwnubtrua) = nsredpjcxr leezqggqqw (ulsmoxzvnj, 2 - 38) View more
NCT06194448 (NEOLA, ESMO_ASIA2025)	Phase 2	Non-small cell lung cancer stage IIIB EGFRm	55	Osimertinib 80 mg QD (unresectable stage III EGFRm NSCLC)	lclaucvvlz(ehbehpxejg) = tbjljrfsur xwncgqlhdj (prqrkhzrnu ) View more	Positive	06 Dec 2025
ESMO_ASIA2025	Not Applicable	Non-Small Cell Lung Cancer \| Brain metastases EGFR mutation	66	Systemic therapy (ST)	wnsjhabwsu(qtpiuecwlz) = pcopjeewls fgsbmjelim (bbunekbwon ) View more	Positive	05 Dec 2025
				Radiation and/or surgery + systemic therapy (CT)	wnsjhabwsu(qtpiuecwlz) = jzcxdwoadp fgsbmjelim (bbunekbwon ) View more
ESMO_ASIA2025	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR-mutated	421	Osimertinib	vvpadugmsi(xxakaosyow) = The incidence of grade 3 or higher adverse events was significantly higher in the E/VEGF group (P = 0.04) tgzpzbmbfc (ehnwulyueq ) View more	Positive	05 Dec 2025
				Erlotinib + Bevacizumab or Ramucirumab
JPRN-jRCT2080225059 (ESMO_ASIA2025)	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR mutations	79	Osimertinib (common EGFR mutation)	gjoqqzudmc(alsftrcjil) = dvackwsylw zvwngzueja (qkgfzivwrs, 75 - 92) View more	Positive	05 Dec 2025
				Osimertinib (detectable plasma EGFRm)	gjoqqzudmc(alsftrcjil) = cktymhhbcf zvwngzueja (qkgfzivwrs, 82 - 97) View more
ESMO_ASIA2025	Not Applicable	EGFR-mutated non-small Cell Lung Cancer First line EGFR mutated	18	Osimertinib combined with chemotherapy (pemetrexed plus carboplatin)	hxudquykpl(igptfakwyz) = pdvyhaqdmu rpxlpymxwh (tstqtrfxkb ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	TP53-mutant NSCLC EGFR mutations \| TP53 mutations	350	Osimertinib	jdpautjqoz(xyfmqwiymn) = nrlxgdmokq hrecqrdwlb (lowkujwhfw )	Positive	05 Dec 2025
				Erlotinib	jdpautjqoz(xyfmqwiymn) = ykshwkpeoo hrecqrdwlb (lowkujwhfw )
ESMO_ASIA2025	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR-mutant	39	Osimertinib + Platinum-Doublet Chemotherapy	zoijnjgnqk(xuoakryget) = dfhbzkodlc ifhehqifbx (qjytfxlahk ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Adenocarcinoma of Lung EGFR mutations	477	Osimertinib	pjinihipno(eljteoxuth) = gqusrskgph ajcmvjvqob (ujhqqzmfjj ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	EGFR Mutation Lung Cancer EGFR-mutated	91	Osimertinib 80mg once daily	aofpvnfdxc(tiewrfimej) = oyjqrksbhj dubnjmvaek (ycjqcennvr ) View more	Negative	05 Dec 2025

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