Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia

This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with Aromatase inhibitors (AI), and a retrospective one with patients receiving adjuvant therapy with AI alone. Thus, both primary data collection and secondary use of data will be organized.

Start Date31 Dec 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT07195227

/ Not yet recruitingPhase 2

Phase II Study to Evaluate the Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Hormone Receptor Positive (HR+) Breast Cancer

This trial will study a type of breast cancer defined by the expression of hormone receptor in the cancer cells (HR+). Patients will be treated with ribociclib, a cyclin-dependent kinase inhibitor, and camizestrant, a selective estrogen receptor degrader (SERD) and complete ER antagonist. The main purpose of the Study is to analyze the efficacy (to find out how effective a treatment is) of ribociclib in combination with camizestrant in patients with advanced HR+ breast cancer who have received endocrine therapy (ET) in early breast cancer setting for at least 5 years, of which at least 2 years with aromatase inhibitor (AI). Ribociclib plus camizestrant efficacy will be determined by assessing the period from treatment initiation until disease progression, defined as progression free survival (PFS).
The anticipated favorable clinical benefits of the combination of ribociclib and camizestrant therapy are projected to outweigh the risks of this treatment. This Study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.

Start Date01 Dec 2025

Sponsor / Collaborator

Medica Scientia Innovation Research SL

CTIS2024-520290-12-00

/ RecruitingPhase 4

TYPER– A Randomized Controlled Study Evaluating the Effectiveness of Typology-based Coaching on Therapy Management for Patients with HR+ HER2- Early Breast Cancer Under Adjuvant Treatment with Ribociclib

Start Date04 Nov 2025

Sponsor / Collaborator-

100 Clinical Results associated with Ribociclib Succinate

100 Translational Medicine associated with Ribociclib Succinate

100 Patents (Medical) associated with Ribociclib Succinate

1,298

Literatures (Medical) associated with Ribociclib Succinate

01 Jan 2026·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

Multi-omics integrative analysis elucidates the molecular characteristics of SMARCA4-deficient lung adenocarcinoma and the derived therapeutic options

Article

Author: Dong, Wei ; Chi, Yuxiang ; Wang, Kai ; Du, Jiajun ; Guo, Deyu ; Sun, Shijie

SMARCA4-deficient lung adenocarcinoma (LUAD) is highly aggressive with multiple oncogene mutations, and has low sensitivity to chemotherapy, targeted therapy and immunotherapy. By integrating multi-omics analysis and machine learning analysis on 20 lung adenocarcinoma datasets, we characterized SMARCA4 mutation in clinical prognosis, metabolic level, immune infiltration and pathway enrichment. The key role of SMARCA4 in LUAD development was confirmed by several in vitro and in vivo experiments. SMARCA4 is highly expressed in LUAD tissues compared with adjacent tissues, and SMARCA4 mutation is a poor prognostic factor. Although SMARCA4-deficient LUAD patients are not sensitive to common chemotherapeutic drugs, immunotherapy is an alternative treatment for lung adenocarcinoma. SMARCA4 deletion is associated with a high rate of oncogene co-mutation. Co-mutation of KRAS was found to have a significant impact on the response to multiple types of chemotherapy. Unique metabolic profiles, abnormal cell cycle and hyperactivation of oxidative phosphorylation were hallmarks of SMARCA4 mutant LUAD. We screened four chemotherapeutic agents targeting MTOR pathway, oxidative stress, DNA replication or cell cycle, including rapamycin and ribociclib, as potential chemotherapeutic agents for SMARCA4-deficient lung adenocarcinoma. In vitro assays showed that SMARCA4 knockdown significantly inhibited DNA replication, cell cycle and cell proliferation in lung adenocarcinoma cells, and significantly promoted oxidative stress and apoptosis in lung adenocarcinoma cells. Our comprehensive findings advance our understanding of SMARCA4 mutant LUAD gene mutation and immune microenvironment, providing insights into potential therapeutic approaches and research directions for SMARCA4-deficient LUAD.

01 Jan 2026·Radiology case reports

Symptomatic bone marrow involvement by metastatic occult HR+/HER2- breast cancer treated with ribociclib and letrozole: A case report

Article

Author: Golemba, Alfredo S ; Tolosa, Raúl E García ; Aguirre Santamaría, Astor A ; Jimenez Bolaño, Adriana L

Visceral crisis (VC) occurs in less than about 15% of patients with de novo metastatic breast cancer (BC). We present a case of a 59-years-old woman who presented with history of bone pain, fatigue, dyspnea on exertion, and weight loss; on physical examination was found no breast nodules, enlarged lymph nodes, or enlarged viscera were palpable. Laboratory tests revealed hemoglobin 5.8 g/dl. PET CT scan showed multiple osteolytic lesions. A bone marrow biopsy was performed, which identified infiltration by an epithelial tumor lesion. Immunohistochemistry showed positivity for CK1/3, CK7, Gata-3, and estrogen and progesterone receptors. HER2 negative (0+). The diagnosis of de novo occult HR+/HER2- metastatic BC was made. Systemic treatment with ribociclib and letrozole was started; the patient experienced clinical improvement of the symptoms, weight gain and improvement in hemoglobin levels. VC in HR+/HER2- metastatic BC is a challenging situation from its definition to its management. In case of availability and quick access, a free CT regimen with CDK4/6i + endocrine therapy could be a option to consider in this patients. This also represents a challenge in terms of cost-effectiveness in the health systems of low-income countries.

01 Dec 2025·Eating Behaviors

Medications as precipitating factors for potential eating disorders: A disproportionality analysis using FDA adverse event reports

Article

Author: Zhang, Shuang ; Zheng, Liyun

OBJECTIVE:

Compared to psychosocial factors, medications remain less well recognized as precipitating factors for eating disorders. This study aims to identify medications potentially associated with eating disorders using the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database.

METHODS:

FAERS reports related to potential eating disorders from January 2004 to December 2024 were retrieved. Reporting odds ratios (RORs) were calculated to detect disproportionate signals, with Fisher's exact test and Bonferroni correction applied for adjustments in multiple comparisons. Drugs exhibiting significant positive signals (ROR 95 % confidence interval lower bound >1, adjusted p-value < 0.01) with over 100 reports were selected for LASSO regression analysis. Logistic regression, adjusted for age, sex, and reporter type, was employed to identify precipitating drugs.

RESULTS:

Among 20,145 reports, 62.7 % involved females, with a median age of 59 years (interquartile range: 42-71). Thirty drugs showed significant positive signals. Nine potential precipitating medications were identified through LASSO and logistic regression, including octreotide, ribociclib, sunitinib, rivastigmine, everolimus, quetiapine, palbociclib, esomeprazole, and pregabalin.

CONCLUSION:

This study identifies certain medications that may act as precipitating factors for potential eating disorders, particularly in middle-aged and older populations. Clinicians should monitor these medications that affect appetite, weight, or carry abuse potential to prevent harm, especially in patients with eating disorders or at-risk populations.

400

News (Medical) associated with Ribociclib Succinate

02 Dec 2025

·www.businesswire.com

Natera to Present 12 Datasets Including >50,000 Patients Featuring Signatera™ at the San Antonio Breast Cancer Symposium

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that at least twelve abstracts highlighting Signatera will be shared at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place December 9-12. The presentations encompass aggregated data from more than 50,000 patients in real-world evidence and prospective clinical studies, demonstrating the prognostic and predictive power of Signatera across diverse breast cancer subtypes and settings. These include real-world studies of Signatera adoption and clinical impact at Yale, Houston Methodist and other leading institutions. Additional highlights include: Signatera Genome study In a real-world cohort of 227 patients with triple-negative, HR+/HER2- and HER2+ breast cancers, during surveillance Signatera Genome detected recurrence with a sensitivity and specificity of 100%. Patients who were Signatera-positive within 3 months of surgery were at a significantly higher risk of distant disease recurrence (HR: 13.1, 95% CI: 1.4-122.1, P = 0.005). Signatera positivity at any time post-definitive treatment was associated with significantly worse distant recurrence-free survival (HR: 221.2, 95% CI: 131.0-373.4, P <0.0001). LEADER trial This phase 2 randomized study aims to evaluate the efficacy of adding the CDK4/6 inhibitor, ribociclib, to adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer who test Signatera-positive during surveillance. Patients with sustained MRD negativity remained disease-free during extended followup (12−month NPV: RFS=99%, DRFS=100%). MRD-positive patients initiating ribociclib achieved high rates of ctDNA decrease or clearance, translating to delayed onset of distant recurrence (18.6 vs 5.4 from treatment start). “We are proud to share our largest dataset for SABCS thus far, featuring the value of Signatera in risk stratification, the early detection of molecular relapse and treatment response monitoring,” said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. “The findings from these prospective clinical studies and real-world evidence add important context on how Signatera can provide personalized insights and optimize treatment across all breast cancer subtypes and indications, and the new data with Signatera Genome offer even greater promise for MRD testing.” The full list of presentations at SABCS includes: December 10, 4:30 PM CT | RF3-04 (Oral Presentation) Presenter: Heather A. Parsons Tumor-informed circulating tumor DNA analysis to assess molecular residual disease for prognosis and prediction of benefit from palbociclib in the PALLAS trial December 10, 5:00 PM CT | PS2-09-04 Presenter: Julia Foldi Predicting outcomes for patients with mixed ductal/lobular carcinoma of the breast based on circulating tumor DNA positivity patterns December 10, 5:00 PM CT | PS2-10-03 Presenter: Devora Isserfoff Impact of Circulating Tumor DNA (ctDNA) monitoring on Patient Anxiety and Clinician Decision-Making in Early-Stage Breast Cancer (PACE-ctDNA) December 10, 5:00 PM CT | PS2-08-21 Presenter: Amy J. Xu Circulating tumor DNA (ctDNA) Dynamics in Early-stage Breast Cancer Patients (pts) with Brain Metastases December 10, 5:00 PM CT | PS2-08-12 Presenter: Julia Foldi Age-associated divergence in breast cancer: clinical, molecular, and genomic insights from a large real-world cohort December 10, 5:00 PM CT | PS2-09-20 Presenter: Daniel Stover Circulating Tumor DNA Dynamics and Anatomical Patterns of Relapse Following Curative Therapy in Early-Stage Breast Cancer December 10, 5:00 PM CT | PS2-07-26 Presenter: Wassim McHayleh Clinical performance of Signatera Genome assay for predicting recurrence in patients with breast cancer December 11, 7:00 AM CT | PD6-07 (Poster Spotlight) Presenter: Mark Jesus Magbanua ctDNA dynamics is most predictive of response in treatment-sensitive response-predictive subtypes of breast cancer: Results from the I-SPY2 trial December 11, 7:00 AM CT | PD5-01 (Poster Spotlight) Presenter: Arielle J. Medford Personalized circulating tumor DNA (ctDNA) testing, intervention, and temporal dynamics in ER+/HER2- early-stage breast cancer (LEADER) December 11, 7:00 AM CT | PD9-01 (Poster Spotlight) Presenter: Steffi Oesterreich Comprehensive Genomic Landscape of Invasive Lobular Carcinoma Reveals Distinct Molecular Subtypes December 11, 12:30 PM CT | PS3-01-05 Presenter: Banu Arun Prevalence and Characterization of Germline CDH1 Mutations in a Large Real-World Breast Cancer Cohort December 11, 5:00 PM CT | PS4-02-25 Presenter: Minhal Zaidi Single Institution experience of longitudinal post-surgical circulating tumor DNA monitoring in patients with HER2+ breast cancer About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 325 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com. Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Clinical ResultPhase 2

25 Nov 2025

·www.globenewswire.com

Novartis data underscore pioneering scientific innovation in Hematology and Oncology at ASH and SABCS

Positive results from ianalumab pivotal Phase III trial in ITP patients previously treated with corticosteroids to be presented as late-breakerScemblix data across clinical and real-world settings offer new evidence informing CML care amid evolving patient needs 96-week pelabresib Phase III data represent longest follow-up of first-line myelofibrosis patients in randomized combination trialKisqali NATALEE and MONALEESA data add to evidence of long-term benefits for early and metastatic breast cancer patients Basel, November 25, 2025 – Novartis will present data from over 70 abstracts, including investigator-initiated trials at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition and 2025 San Antonio Breast Cancer Symposium® (SABCS). Featured among these latest advances in hematology and oncology are 11 oral presentations, with the Phase III VAYHIT2 trial for ianalumab in immune thrombocytopenia (ITP) accepted as a late-breaker abstract.“For decades, Novartis has redefined the future of hematology and oncology, and we’re building on that foundation with compelling new data presented at ASH and SABCS,” said Mark Rutstein, M.D., Global Head, Oncology Development, Novartis. “These data underscore how we seek to set new standards for transformative care, with the aim of turning cutting-edge innovation into meaningful impact for patients.”Key highlights of data accepted by ASH include: Abstract Title Abstract Number/ Presentation Details Ianalumab (VAY736)Primary results from VAYHIT2, a randomized, double-blind, Phase 3 trial of ianalumab plus eltrombopag versus placebo plus eltrombopag in patients with primary immune thrombocytopenia (ITP) who failed first-line corticosteroid treatmentAbstract #LBA-2Oral PresentationDecember 9, 7:45 – 8:00 am ETSecondary analysis results from VAYHIT3, a Phase 2 study of ianalumab in patients with primary immune thrombocytopenia previously treated with at least two lines of therapyAbstract #844Oral PresentationDecember 8, 3:30 – 3:45 pm ETScemblix® (asciminib)Asciminib (ASC) demonstrates continued improvement in patient-reported outcomes (PROs) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST week 96 analysisAbstract #1997Poster PresentationDecember 6, 5:30 – 7:30 pm ETImproved long-term tolerability with asciminib (ASC) vs investigator-selected (IS) tyrosine kinase inhibitors (TKIs) in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): Week 96 exploratory analysis of the phase 3 ASC4FIRST trialAbstract #5549Poster PresentationDecember 8, 6:00 – 8:00 pm ETAsciminib (ASC) in chronic myeloid leukemia in chronic Phase (CML-CP): Efficacy and safety results of the Phase 2 ASC2ESCALATE trial in the cohort of patients (pts) with 1 prior tyrosine kinase inhibitor (TKI)Abstract #906Oral PresentationDecember 8, 4:00 – 4:15 pm ETA comparison of real-world outcomes of asciminib versus ATP-competitive tyrosine kinase inhibitors as second-line treatment in patients with chronic myeloid leukemia in chronic phaseAbstract #724Oral PresentationDecember 7, 5:15 – 5:30 pm ETPelabresib (DAK539)Durable efficacy and long-term safety with pelabresib plus ruxolitinib in JAK Inhibitor–Naive myelofibrosis: 96-week Results from the Phase III MANIFEST-2 studyAbstract #910Oral PresentationDecember 8, 3:30 – 3:45pm ETRapcabtagene autoleucel (YTB323)Rapcabtagene autoleucel (YTB323) for patients with first line high-risk large B-cell lymphoma: phase II interim resultsAbstract #670Oral PresentationDecember 7, 5:15 – 5:30 pm ETFabhalta® (iptacopan)Oral iptacopan monotherapy demonstrates clinically meaningful hemoglobin increases in patients with paroxysmal nocturnal hemoglobinuria with baseline hemoglobin levels 10 to <12 g/dL on anti-C5 therapy: Subgroup analysis of the APPULSE-PNH Phase 3b trialAbstract #4981Poster PresentationDecember 8, 6:00 – 8:00 pm ETLong-term safety and efficacy of iptacopan in patients with paroxysmal nocturnal hemoglobinuria: 4- and 5-year follow-up of patients from phase 2 studies who entered the roll-over extension programAbstract #3198Poster PresentationDecember 7, 6:00 – 8:00 pm ETThe 2-year efficacy and safety of iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria with a history of aplastic anemia on concomitant immunosuppressive therapy who entered the roll-over extension programAbstract #4978Poster PresentationDecember 8, 6:00 – 8:00 pm ET Key highlights of data accepted by SABCS include: Kisqali® (ribociclib)Pooled analysis of patients (pts) treated with 1st-line (1L) ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) studies: long-term progression-free survival (PFS)Abstract # PD5-10Poster Spotlight PresentationDecember 11, 8:09 – 8:12 am CSTFive-year analysis of distant disease-free survival (DDFS) across key subgroups from the phase 3 NATALEE trial of ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) in patients with HR+/HER2− early breast cancer (EBC)Abstract # PS3-09-08Poster PresentationDecember 11, 12:30 – 2:00 pm CSTProgression-free survival (PFS) and overall survival (OS) results from the phase 3 MONALEESA-3 trial of postmenopausal patients with hormone receptor–positive (HR+)/HER2-negative (HER2−) advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL): A subgroup analysis of patients with invasive lobular carcinoma (ILC) Abstract # PS1-10-27 Poster PresentationDecember 10, 12:30 – 2:00 pm CSTRibociclib drug-drug interaction and concomitant medication management in early and advanced breast cancer patientsAbstract # PS3-09-15Poster PresentationDecember 11, 12:30 – 2:00 pm CSTReal-world patient (pt) and caregiver experiences with breast cancer (BC) risk of recurrence (ROR) in the US: Results of an Online Survey and Social Media Analysis Abstract # PS1-04-17Poster PresentationDecember 10, 12:30 – 2:00 pm CSTRepower: a real-world noninterventional study of outcomes and experiences in patients with hormone receptor-positive (HR+)/human epidermal growth fact receptor 2-negative (HER2−) early breast cancer (EBC) treated with an adjuvant cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) plus endocrine therapy (ET) Abstract # PS3-08-27Poster PresentationDecember 11, 12:30 – 2:00 pm CST Product InformationFor full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products.Novartis in hematologyOur legacy in hematology runs deep, shaped by over 25 years of progress, partnerships and a commitment to keep asking questions, challenging norms and striving for better answers in a uniquely complex field. In the past two decades, we have delivered more than 10 medicines across more than 15 blood cancers and serious blood disorders including leading the era of targeted therapies in cancer and bringing the first CAR-T therapy to patients. Innovation in hematology has brought significant progress, yet patients and clinicians continue to face persistent challenges. We’re forging the future of hematology, powered by our foundation in scientific discovery to deliver meaningful change for patients with unmet needs.Novartis in breast cancer For over 30 years, Novartis has been at the forefront of driving scientific advancements for individuals affected by breast cancer and enhancing clinical practice in collaboration with the global community. With one of the most comprehensive breast cancer portfolios and pipeline, Novartis leads the industry in discovery of new therapies and combinations in HR+/HER2- breast cancer, the most common form of the disease. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. # # # Novartis Media RelationsE-mail: media.relations@novartis.comNovartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com

Phase 2Phase 3Clinical ResultASHImmunotherapy

21 Nov 2025

·www.biopharmadive.com

FDA tests new program to speed drugmaker talks; Bezos-linked AI startup raises $106M

Today, a brief rundown of news from The Food and Drug Administration and Profluent, as well as updates from Novartis, Innovent Biologics and Flagship Pioneering that you may have missed.The Food and Drug Administration announced a new pilot program intended to speed up communications with drugmakers following formal meetings. The new program allows companies the opportunity after a meeting to submit an email question to agency staff asking for a quick clarification regarding a specific issue. The FDA then aims to respond within three business days. The pilot is initially being tested out through the agencys Office of New Drugs, but could eventually be expanded more widely. Numerous drug developers have told me that a quick touchpoint or clarification opportunity with the FDA team could spare them months of guesswork, said Commissioner Martin Makary, in a statement. Ben FidlerNovartis hiked the sales estimates for two of its top drugs and revealed plans this week to expand its manufacturing footprint in North Carolina. On Thursday, Novartis raised its projections for the leukemia medicine Scemblix and the breast cancer therapy Kisqali, which it now expects to peak at more than $14 billion combined annually. A day earlier, Novartis said itll build three new sites in North Carolina producing biologics, tablets, sterile packaging and more. The new plans are part of a $23 billion U.S. drug production pledge Novartis made earlier this year. Ben FidlerBezos Expeditions, the private investment office of Jeff Bezos, teamed with a group of investors to pour $106 million into AI-focused startup Profluent. In an announcement Wednesday, Profluent said itll direct the cash towards generative AI systems that can help design novel proteins that, in turn, can be used to make new drugs or better agricultural crops. Profluent's Protein Atlas has already made more than 115 billion unique proteins, which it claims is the worlds largest data resource of its kind. The startup is already worth close to $1 billion, according to a Forbes report. Ben FidlerAn experimental obesity drug Innovent Biologics is codeveloping with Eli Lilly is headed towards a regulatory submission in China. Innovent said Wednesday that the drug, which stimulates the two gut hormones GLP-1 and glucagon, met all of its main and key secondary goals in a Phase 3 trial in China, spurring as much as about 19% weight loss over 60 weeks in adults with obesity compared to 3% for placebo recipients. An approval application will be filed for the medication, called mazdutide, in the near term, the company said. Lilly and Innovent have collaborated on multiple drugs over the last several years and, in 2019, added mazdutide to their alliance. Ben FidlerFlagship Pioneering on Thursday revealed new developments related to a 2024 collaboration with GSK, announcing agreementsbetween the pharma and its startups ProFound Therapeutics and Quotient Therapeutics. ProFound will help GSK unearth treatments for chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis. Quotient, meanwhile, will search for drug targets for those two conditions, as well as metabolic dysfunction-associated steatohepatitis. If GSK decides to continue on, both startups will handle key preclinical activities, after which the big drugmaker will have the option to advance programs coming from the work into human testing.GSK and Flagships deal last year enabled the pharma company to dip into the venture firms portfolio of startups to find up to 10 new medicines or vaccines. Gwendolyn Wu '

Phase 3Drug ApprovalClinical Result

100 Deals associated with Ribociclib Succinate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ribociclib Succinate	L01XE	DB11730

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced breast cancer	Canada	Novartis Pharmaceuticals Canada, Inc.	02 Mar 2018
Metastatic breast cancer	Canada	Novartis Pharmaceuticals Canada, Inc.	02 Mar 2018
Hormone receptor positive HER2 negative breast cancer	United States	Novartis Pharmaceuticals Corp.	13 Mar 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced HER2-Positive Breast Carcinoma	Phase 3	United States	Novartis AG	28 Mar 2022
Advanced HER2-Positive Breast Carcinoma	Phase 3	Portugal	Novartis AG	28 Mar 2022
Advanced HER2-Positive Breast Carcinoma	Phase 3	Spain	Novartis AG	28 Mar 2022
Early Stage Breast Carcinoma	Phase 3	-	Novartis Pharmaceuticals Corp.	31 Mar 2018
HER2-negative breast cancer	Phase 3	Italy	Novartis Pharmaceuticals Corp.	02 Feb 2018
Leukodystrophy, Hypomyelinating, 6	Phase 3	Italy	Novartis Pharmaceuticals Corp.	02 Feb 2018
Locally advanced breast cancer	Phase 3	Italy	Novartis Pharmaceuticals Corp.	02 Feb 2018
Breast Cancer	Phase 3	United States	Novartis Pharmaceuticals Corp.	07 Jun 2017
Advanced cancer	Phase 3	United States	Novartis Pharmaceuticals Corp.	30 Nov 2016
Advanced cancer	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	30 Nov 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03822468 (AMALEE, Pubmed \| JAMA Oncol)	Phase 2	Advanced breast cancer First line HR+/ERBB2-	376	Ribociclib 600 mg + a nonsteroidal aromatase inhibitor (premenopausal patients also received goserelin)	rjcgrmduqf(iotgtchtzh): ratio = 0.87 (90.0% CI, 0.74 - 1.03)	Negative	01 Nov 2025
				Ribociclib 400 mg + a nonsteroidal aromatase inhibitor (premenopausal patients also received goserelin)
NCT03701334 (NATALEE, Pubmed \| JAMA Oncol)	Phase 3	Hormone receptor positive HER2 negative breast cancer Adjuvant hormone receptor-positive \| ERBB2 (formerly HER2)-negative	5,101	Ribociclib plus NSAI	zljgvjtkbl(jvzguvxfsr) = fvjdfpcjvo pzmzqgscca (tunzrpkegg ) View more	Positive	01 Nov 2025
				NSAI alone	zljgvjtkbl(jvzguvxfsr) = fzfyxlmnfz pzmzqgscca (tunzrpkegg ) View more
ESMO2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2-	6,796	Palbociclib + Palbociclibherapy	zuzxymlrkm(urnuikmeiv): HR = 0.81 (95.0% CI, 0.66 - 0.99), P-Value = 0.043 View more	Positive	17 Oct 2025
				Ribociclib + RibociclibTherapy
NCT05508906 (ESMO2025)	Phase 1/2	ER-positive/HER2-negative Breast Cancer ER+ \| HER2-	72	Palazestrant 120 mg plus ribociclib	svlsxcyvrn(nxmrgtlthh) = 35% ljuxalyykl (dfhtxsvlqf ) View more	Positive	17 Oct 2025
				Palazestrant 120 mg plus ribociclib (prior CDK4/6i)
NCT03701334 (NATALEE, ESMO2025)	Phase 3	Neoadjuvant HR+/HER2−	2,180	ribociclib+NSAI	pzwlpolkch(pbtusodsbc) = jyzqwcdezj zylygphdck (pmvdfphywj ) View more	Positive	17 Oct 2025
				NSAI alone	pzwlpolkch(pbtusodsbc) = lfpfntqjwn zylygphdck (pmvdfphywj ) View more
ESMO2025	Not Applicable	First line \| Second line	239	Palbociclib	murmdewhxl(madhsndskg) = ueezenxcvh pottajwnoo (iferzyqnif )	Positive	17 Oct 2025
				Ribociclib/Abemaciclib	murmdewhxl(madhsndskg) = rrzatfidxk pottajwnoo (iferzyqnif )
NATALEE (ESMO2025)	Phase 3	Early Stage Breast Carcinoma Adjuvant HR+/HER2−	3,738	Ribociclib + NSAI	ifomidsabn(flwytllmzy) = qbowuhhqji pbbufkwpzf (eanzwpptrj ) View more	Positive	17 Oct 2025
				NSAI alone	ifomidsabn(flwytllmzy) = ceqhggnuts pbbufkwpzf (eanzwpptrj ) View more
ESMO2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+/HER2−	352	Ribociclib plus endocrine therapy	lfjtcdylqg(ffbpxuouuq) = cfhlogtbwe jwdhebjqmw (ikroeqkkbp, 0.94 - 1.27) View more	Negative	17 Oct 2025
REALEESA (ESMO2025)	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+/HER2-	132	Ribociclib plus HT	vdjinmohwa(lrwslaeuko) = Musculoskeletal disorders were the most frequent AE (46.3%), followed by infections (24.4%) and neutropenia (20.7%). kkabonfdlk (bkiokdajpa )	Positive	17 Oct 2025
NCT05296746 (RIBOLARIS, ESMO2025)	Phase 2	ER-positive/HER2-negative Breast Cancer Neoadjuvant HR+ \| HER2-	686	Ribociclib + Endocrine Therapy	eoimonopld(utchvtliar) = kcqmnaijfr dnrfpxkbjl (sbcsgvrohi, 10.5 - 12.2)	Positive	17 Oct 2025

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