Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (AI). The purpose of the app is to increase adherence to treatment by informing patients about the risks of relapse and adverse event prevention and treatment.

Start Date31 Jul 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06930859

/ Not yet recruitingNot Applicable

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 Jul 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06849947

/ Not yet recruitingPhase 2IIT

Randomized Phase II Trial of Fulvestrant With Ribociclib Versus Physician's Choice Treatments for the Patients Who Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as First Line Treatment (CLEE011AKR06R)

▪ Fulvestrant With Ribociclib versus Physician's choice treatments for the patients who recurred after completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as first line treatment

Start Date30 Jun 2025

Sponsor / Collaborator

Samsung Medical Center

100 Clinical Results associated with Ribociclib Succinate

100 Translational Medicine associated with Ribociclib Succinate

100 Patents (Medical) associated with Ribociclib Succinate

1,347

Literatures (Medical) associated with Ribociclib Succinate

01 May 2025·INTERNATIONAL JOURNAL OF CANCER

Head‐to‐head comparison of palbociclib and ribociclib in first‐line treatment of HR‐positive/HER2‐negative metastatic breast cancer with real‐world data from the OPAL registry

Article

Author: Decker, Thomas ; Harbeck, Nadia ; Fricker, Roland ; Nusch, Arnd ; Zahn, Mark‐Oliver ; Wöckel, Achim ; Hagen, Volker ; Thill, Marc ; Welt, Anja ; Stickeler, Elmar ; Kaltenecker, Gabriele ; Dille, Stephanie ; Engelken, Kathrin ; Ringwald, Kai ; Zaiss, Matthias ; Kruggel, Lisa ; Gratzke, Katja ; Schulz, Holger ; Jänicke, Martina

Abstract:

Cyclin‐dependent kinase 4/6 inhibitors (CDKIs) in combination with endocrine therapy (ET) are the standard‐of‐care in the first‐line treatment of HR‐positive, HER2‐negative metastatic breast cancer. In the absence of direct head‐to‐head trials comparing the efficacy and safety of the different CDKIs, the individual choice of treatment in everyday practice is complex. Inverse probability of treatment weighting was used to emulate a head‐to‐head comparison of palbociclib +ET (PALBO) and ribociclib +ET (RIBO) in patients recruited into the prospective, observational, multicenter registry platform OPAL (NCT03417115). Progression‐free survival (PFS), overall survival (OS) and quality of life surveys were analyzed, also for subgroups stratified by treatment‐free interval (TFI). A total of 623 patients with HR‐positive, HER2‐negative metastatic breast cancer received PALBO (n = 388) or RIBO (n = 235) in their first line of treatment. No difference between PALBO and RIBO was found for PFS (median 26.7 months [23.6, 30.7] vs. 27.0 months [21.1, 30.4], HR 1.01 [0.80, 1.27]) and OS (median 42.4 months [38.8, 50.3] vs. 49.3 months [36.9, NA], HR 0.96 [0.71, 1.28]). There was a trend for longer PFS and OS in patients with TFI <12 months receiving RIBO. Patients reported comparable side effects for both CDKIs. This head‐to‐head comparison revealed no difference in PFS and OS between PALBO and RIBO, however, a trend to longer PFS and OS with RIBO was observed in the subgroup of patients with TFI <12 months. Side effects experienced with PALBO and RIBO highlight the important toxicities to be addressed during treatment decision.

01 May 2025·BREAST CANCER RESEARCH AND TREATMENT

Patient preferences for CDK4/6 inhibitor treatments in HR+/HER2− early breast cancer: a discrete choice survey study

Article

Author: Lustberg, Maryam B ; Santarsiero, Liz ; Latremouille-Viau, Dominick ; Mayer, Erica L ; Morlock, Robert ; Meng, Yan ; Hazra, Nisha C ; Smith, Mary Lou ; Guérin, Annie ; Qu, Wendi ; Bellefleur, Remi ; Ganapathy, Vaidyanathan

PURPOSE:

Adding CDK4/6 inhibitors (CDK4/6is) to endocrine therapy (ET) for HR+/HER2- early breast cancer (EBC) demonstrated statistically significant invasive disease-free survival (iDFS) benefits in monarchE (node positive, high risk, stage II/III) and NATALEE (select N0 and all macroscopic N1, stage II/III). This study evaluated patient preferences for EBC treatment attributes and how these may translate for CDK4/6i selection.

METHODS:

A web-based discrete choice experiment survey was conducted among US-based adult women with self-reported stage II/III HR+/HER2- EBC. Eight attributes were included, informed by 14 qualitative interviews (to identify most relevant attributes), expert clinical input, and differentiating features between CDK4/6is: efficacy (5-year iDFS), adverse events (venous thromboembolic event [VTE], diarrhea, fatigue), number of blood tests, number of electrocardiograms (EKGs), treatment duration, and schedule. Participants selected scenarios that best reflected their preferences from 10 choice cards, each displaying a pair of hypothetical treatment profiles. A conditional logit regression model was used to estimate preference weights and relative importance (RI) of attributes.

RESULTS:

A total of 409 women participated. Patient preferences, from high to low RI, were higher efficacy, lower diarrhea risk, lower fatigue risk, shorter treatment duration, and lower VTE risk. Number of blood tests, number of EKGs, and treatment schedule were less important. Utility scores were higher for reconstructed treatment profiles that resembled ribociclib.

CONCLUSION:

This study demonstrated that patients prefer adjuvant treatment with higher efficacy and lower risk of adverse events. These data will aid shared decision-making when discussing the addition of CDK4/6is to adjuvant ET for eligible patients with HR+/HER2- EBC.

03 Apr 2025·Expert Review of Anticancer Therapy

Modified cachexia index and survival in metastatic breast cancer patients treated with CDK 4–6 inhibitors

Article

Author: Şavklıyıldız, Mehmet ; Baş, Onur ; Şahin, Taha Koray ; Aksoy, Sercan ; Yazarkan, Yiğit ; Tokatlı, Mert ; Guven, Deniz Can ; Karahan, Latif ; Guduk, Naciye ; Kılınç, Can

BACKGROUND:

The objective of this study is to evaluate the correlation between survival outcomes and the modified cachexia index (mCXI) in patients with metastatic breast cancer who have been treated with cyclin-dependent kinase (CDK) 4/6 inhibitors.

METHODS:

This study was conducted on patients with metastatic breast cancer who received CDK 4/6 inhibitors (either Palbociclib or Ribociclib) between January 2020 and November 2024.

RESULTS:

240 patients were included. A total of 236 patients (98.3%) were female. Median age was 57 (IQR: 48-66 years). The median follow-up period from the initiation of CDK 4/6 inhibitors to the last control was 20 months. One hundred eighty-four patients (76.7%) received ribociclib, while 56 (23.3%) received palbociclib. At diagnosis, 179 patients (74.6%) had metastatic disease. Patients are classified as modified cachexia index-low (mCXI-Low) and mCXI-High according to the receiver operating characteristic (ROC) analysis results for overall survival (OS) prediction [AUC: 0,654 p:<0,001 Cut-off value = 93.5]. Following multivariate analysis, both progression-free survival [HR: 1.50 (95% CI 1.07-2.12), p = 0.02] and overall survival [HR: 3.22 (95% CI 1.90-5.46), p < 0.001] were found to be significantly associated with mCXI.

CONCLUSION:

mCXI is associated with overall survival in metastatic breast cancer patients who are treated with CDK 4-6 inhibitors.

338

News (Medical) associated with Ribociclib Succinate

24 Apr 2025

·www.prnewswire.com

IBRANCE's Market Growth Marks a Significant Step Forward in Metastatic HR+/HER2− Breast Cancer Treatment Landscape | DelveInsight

Since its launch in 2015, it has been prescribed to more than 200,000 patients globally. The drug is currently approved for use in both men and women, expanding its market potential. Despite facing competition from other CDK4/6 inhibitors like Novartis' KISQALI and Eli Lilly's VERZENIO, IBRANCE maintains a strong position in the metastatic setting. LAS VEGAS, April 24, 2025 /PRNewswire/ -- DelveInsight's " IBRANCE Market Size, Forecast, and Market Insight Report" highlights the details around IBRANCE, a CDK4/6 inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of IBRANCE. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Pfizer's IBRANCE (palbociclib) Overview IBRANCE is an oral medication that inhibits CDKs 4 and 6, which are crucial regulators of the cell cycle that drive cellular progression. In the U.S., IBRANCE is approved for treating adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. It is used in combination with an aromatase inhibitor as a first-line endocrine therapy for postmenopausal women or men or with fulvestrant for patients whose disease has progressed after endocrine treatment. IBRANCE is currently authorized in over 90 countries and has been prescribed to more than 200,000 patients worldwide. Learn more about IBRANCE projected market size for metastatic HR+/HER2− breast cancer @ IBRANCE Market Potential The HR+ HER2- subtype is the most commonly found type of breast cancer, characterized by cancer cells that have estrogen and progesterone receptors but do not overexpress HER2. A patient's journey typically begins with the onset of concerning symptoms, leading to a comprehensive clinical evaluation and various imaging tests. DelveInsight estimates that approximately 211K new cases of HR+/HER2– breast cancer occurred in the US in 2024. CDK4/6 inhibitors currently dominate the first-line treatment market and represent a significant advancement in the management of HR+/HER2-ve breast cancer. The data from large, randomized clinical trials are both strong and consistent. While single-agent endocrine therapies have shown limited benefits in the first and subsequent treatment lines for women with ER-positive metastatic breast cancer (mBC), combination therapies have emerged as a more effective option for many patients. In recent years, the treatment landscape for HR+/HER2−ve breast cancer has been transformed with the introduction of highly active targeted therapies, including CDK4/6 inhibitors, mTOR inhibitors, PARP inhibitors, new oral SERDs, and PI3K inhibitors. These advances have expanded the range of treatment options and improved survival outcomes for these patients. The market for metastatic HR+/HER2− breast cancer in the 7MM is projected to grow during the forecast period (2025–2034) due to the introduction of several novel therapies in the market. Discover more about the metastatic HR+/HER2− breast cancer market in detail @ Metastatic HR+/HER2− Breast Cancer Market Report Emerging Competitors of IBRANCE Some of the drugs in the pipeline include Gedatolisib (Celcuity), ARV-471 (Arvinas and Pfizer), OP-1250 (Olema Pharmaceuticals), KEYTRUDA (Merck), and Rupitasertib (Evexta Bio), among others. In December 2024, Arvinas and Pfizer presented preliminary data from the ongoing Phase 1b portion of the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib among patients with locally advanced or metastatic ER+/HER2- breast cancer at the San Antonio Breast Cancer Symposium (SABCS) 2024. In December 2024, Olema Pharmaceuticals presented clinical results from the ongoing Phase Ib/II study of palazestrant in combination with ribociclib in patients with ER+/HER2- advanced or metastatic breast cancer at SABCS 2024. To know more about the number of competing drugs in development, visit @ IBRANCE Market Positioning Compared to Other Drugs Key Milestones of IBRANCE In February 2021, Pfizer Inc. announced that the U.S. Patent and Trademark Office (USPTO) has granted a U.S. Patent Term Extension (PTE) certificate for IBRANCE. This extension prolongs the validity of U.S. Patent No. RE47,739 ('739) by over four years, now lasting until March 5, 2027. In April 2019, Pfizer announced that the FDA has approved a supplemental New Drug Application (sNDA) to broaden the uses of IBRANCE in combination with an aromatase inhibitor or fulvestrant, now including men with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced or metastatic breast cancer. In March 2017, Pfizer Inc. revealed that the FDA has approved a supplemental New Drug Application (sNDA) for IBRANCE, its pioneering cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor, following the positive outcomes from the confirmatory Phase 3 trial PALOMA-2. In September 2016, Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had issued a positive recommendation for the marketing authorization of IBRANCE® (palbociclib) in the European Union (EU). This recommendation is for its use in treating women with hormone receptor-positive, HER2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. In February 2016, Pfizer announced that the FDA has approved a new indication for IBRANCE 125mg capsules, expanding its use. The approval allows IBRANCE to be used in combination with fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in women whose disease has progressed after endocrine therapy. In February 2015, Pfizer announced that the FDA granted accelerated approval for IBRANCE in combination with letrozole to treat postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as the initial endocrine-based therapy for their metastatic disease. Discover how IBRANCE is shaping the metastatic HR+/HER2− breast cancer treatment landscape @ IBRANCE Drug IBRANCE Market Dynamics IBRANCE is a targeted therapy that has revolutionized the treatment of hormone receptor-positive, HER2-negative breast cancer, particularly in combination with aromatase inhibitors or letrozole. Developed by Pfizer, IBRANCE was one of the first CDK4/6 inhibitors approved by the FDA for metastatic breast cancer, and its approval has significantly changed the treatment landscape. The drug works by inhibiting cyclin-dependent kinases 4 and 6, which are key regulators of the cell cycle, thus preventing cancer cells from proliferating. Its market dynamics have been shaped by the growing demand for targeted therapies, as well as the increasing focus on precision medicine and improved patient outcomes. The global market for IBRANCE has been positively impacted by its proven efficacy in clinical trials and its ability to extend progression-free survival in breast cancer patients. The drug's market dominance is underpinned by its widespread acceptance and adoption by oncologists worldwide. However, competition is intensifying, with other CDK4/6 inhibitors such as VERZENIO (abemaciclib) and KISQALI (ribociclib) entering the market, offering similar benefits but with some distinct clinical profiles. This competitive landscape has led to strategic pricing and marketing strategies by Pfizer, aiming to maintain IBRANCE's market leadership while managing pressures from generic alternatives. Additionally, the evolving reimbursement landscape and regulatory policies around oncology drugs are crucial factors influencing the market dynamics. Health insurers and government healthcare programs often scrutinize the cost-effectiveness of cancer treatments, which can impact the pricing and accessibility of IBRANCE in different markets. Another factor is the rising focus on combination therapies, as IBRANCE is often used in conjunction with other drugs like letrozole, which boosts its efficacy and market potential. The shift toward personalized cancer treatment regimens is expected to continue fueling demand for CDK4/6 inhibitors like IBRANCE, especially in more advanced stages of breast cancer. In terms of geographical markets, IBRANCE has seen significant uptake in North America and Europe, where the healthcare infrastructure supports innovative cancer therapies. However, emerging markets, where the economic barriers to accessing expensive cancer treatments can be higher, present a challenge to the widespread use of IBRANCE. Pfizer's ongoing efforts to expand in these regions, through partnerships and pricing adjustments, will be key to ensuring continued growth in global market share. Overall, the IBRANCE market is poised for steady growth, driven by clinical advancements, increasing breast cancer diagnoses, and the continual push toward more targeted, effective therapies. Dive deeper to get more insight into IBRANCE's strengths & weaknesses relative to competitors @ IBRANCE Market Drug Report Table of Contents Related Reports Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies, including Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNtech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, Immutep, among others. HR+/HER2− Breast Cancer Pipeline HR+/HER2− Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HR+/HER2− breast cancer companies, including Regor Therapeuics, Seagen Inc., CytomX Therapeutics, Taizhou EOC Pharma, Chia Tai Tianqing Pharmaceutical Group, AstraZeneca, Daiichi Sankyo, Inc., Tyme, Inc., Seagen Inc., Context Therapeutics, Eisai Inc., Shanghai Hengrui Pharmaceutical Co., Ltd., Jiangsu Simcere Pharmaceutical Co., Kind Pharmaceuticals, Merus N.V., Atossa Therapeutics, Roche, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key breast cancer companies including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. Metastatic Breast Cancer Pipeline Metastatic Breast Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key metastatic breast cancer companies, including Roche, RemeGen, SynCore Biotechnology, Allarity Therapeutics, Daiichi Sankyo Company, Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Byondis B.V., Jiangsu Hansoh Pharmaceutical Co., Ltd., Shanghai Miracogen Inc., Ambrx, Inc., Daehwa Pharmaceutical Co., Ltd., Phoenix Molecular Designs, GlycoMimetics Incorporated, Rhizen Pharmaceuticals SA, Menarini Group, Samus Therapeutics, Inc., Hanmi Pharmaceutical Company Limited, Jiangxi Qingfeng Pharmaceutical Co. Ltd., Immutep Limited, Arvinas Inc., G1 Therapeutics, Mirati Therapeutics Inc., Chia Tai Tianqing Pharmaceutical, Shanghai Pharmaceuticals Holding Co., Ltd, Pfizer, OncoTherapy Science, Inc., Eisai Inc., Dizal Pharmaceuticals, Jiangsu Hengrui Medicine Co., Tyme, Inc, Orion Pharma, HiberCell, Inc., Rhizen Pharmaceuticals SA, Hutchison Medipharma Limited, OncoPep Inc., Taizhou Hanzhong biomedical co. LTD, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3Phase 1Clinical Result

11 Apr 2025

·www.pharmaceutical-technology.com

AstraZeneca’s oral breast cancer drug Truqap greenlit for NHS use

Truqap has been approved patients with the most common type of breast cancer on the NHS. Image credit: Shutterstock/Yakobckuk Viacheslav. AstraZeneca’s Truqap (capivasertib) has been approved for use by the National Health Service (NHS) in England and Wales, providing a new targeted therapy option that significantly increases progression-free survival (PFS) in breast cancer patients. National Institute for Health and Care Excellence (NICE), the spending watchdog for the NHS, has recommended the drug to be used in combination with AstraZeneca’s already-marketed breast cancer drug Faslodex (fulvestrant). Adults with hormone receptor (HR)-positive HER2-negative breast cancer that has one or more PIK3CA, AKT1 or PTEN gene alterations and is locally advanced or metastatic are eligible for the therapy. NICE estimates around 1,100 patients will be able to take the new twice-a-day tablet, with London’s Institute of Cancer Research (ICR) forecasting that the combo therapy will eventually benefit around 3,000 a year. Truqap will likely become a key revenue driver for AstraZeneca. The drug is forecast to reach blockbuster status by 2027, whilst 2031 global sales are expected to hit nearly $2bn, as per GlobalData’s Pharma Intelligence Centre. As well as the UK, Truqap is also approved in the US , the European Union (EU), and Japan, amongst others. GlobalData is the parent company of Pharmaceutical Technology . The HR-positive HER2-negative breast cancer drug market also includes Pfizer’s Ibrance (palbociclib), Eli Lilly’s Verzenio (abemaciclib), and Novartis’ Kisqali (ribociclib). Breast cancer is the most common cancer in the UK, affecting one in seven women. Treatments have progressed over the past few decades, meaning 75% of patients survive for 10 years or more after diagnosis. HR-positive HER2-negative breast cancer is the most common type of breast cancer. Results from the Phase III CAPItello-291 trial (NCT04305496) showed that Truqap doubled the time it took for cancer to progress in 708 women with HR-positive HER2-negative breast cancer patients. The median PFS was 7.3 months in those who received Truqap and Faslodex, compared to 3.1 months in patients who received hormone therapy alone. The NHS availability of Truqap is a ‘triumph’ according to Professor Kristian Helin, chief executive of ICR. “This announcement is a triumph that will improve treatment for these patients with the most common type of advanced breast cancer. Around half of patients with this kind of breast cancer have mutations in one or more of the genes and for these patients, Truqap can halt disease progression. I’m delighted that access to the drug is being expanded to NHS patients in England and Wales who are in desperate need of better options,” Professor Helin commented. Patients with advanced HR-positive HER-2 negative breast cancer in the UK are currently offered the option to continue Faslodex or chemotherapy. Faslodex on its own is often ineffective and chemotherapy carries side effects, the ICR stated. “People with advanced breast cancer would value treatments like [Truqap] that can be given when limited options exist and because it may delay the need for chemotherapy and its associated side-effects,” NICE’s director of medicines evaluation Helen Knight said. Truqap works by inhibiting all three isoforms of the AKT protein. AKT kinases enable cancer cell growth and multiplication. NICE said that whilst there have been no clinical trials directly comparing the new combo therapy to existing approved regimens, indirect comparisons suggest non-inferiority. The recommendation by NICE represents a U-turn after the agency initially rejected the therapy due to uncertainties over its cost-effectiveness. Breast Cancer Now’s chief executive Claire Rowney said this meant “patients faced unnecessary delays in accessing” the treatment. She added that “NHS England must now put in place prompt genetic testing to ensure those eligible to receive [Truqap] without further delay.”

Clinical ResultPhase 3Drug Approval

09 Apr 2025

·www.globenewswire.com

Barbara Weber, M.D., Elected to ITM Supervisory Board

Garching / Munich, Germany, April 09, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the election of Barbara Weber, M.D., to its Supervisory Board, effective May 01, 2025. The election occurred at ITM’s Extraordinary General Meeting. Dr. Weber is the President, Chief Executive Officer and Founder of Tango Therapeutics (Nasdaq: TNGX). She has over 25 years of executive and research and development leadership experience in biotech, venture capital and at major pharmaceutical companies, including Novartis (NYSE: NVS) and GlaxoSmithKline (NYSE: GSK). ITM’s Supervisory Board and the company overall will benefit from Dr. Weber’s deep expertise as it advances its lead Phase 3 candidate, n.c.a. 177Lu-edotreotide (ITM-11), and continues advancing its radiopharmaceutical pipeline and medical radioisotope manufacturing business. “Dr. Weber’s impressive track record in building transformative oncology biotech companies speaks volumes for her business acumen and her dedication to improving the lives of people living with cancer. Her profound industry and scientific knowledge, including her demonstrated ability to bring novel compounds through the clinic to FDA approval, will be an invaluable asset to ITM,” said Udo J. Vetter, Chairman of the Supervisory Board of ITM. “The expansion of our Supervisory Board and its insights ensures that ITM is optimally positioned to continue accelerating the growth of its radiopharmaceutical pipeline and medical radioisotope business.” Dr. Weber is a physician-scientist with a distinguished clinical and academic career and extensive leadership expertise in global pharmaceutical development. As the President, Chief Executive Officer and Founder of Tango Therapeutics, she led the company’s transition to being publicly listed and the development of its precision oncology product candidates based on the genetic principle of synthetic lethality. As a Venture Partner at Third Rock Ventures, she led teams in creating new oncology drug discovery companies, including Tango Therapeutics, Neon Therapeutics (acquired by BioNTech (Nasdaq: BNTX)) and Relay Therapeutics (Nasdaq: RLAY). “As a physician and business executive devoted to fighting cancer, I recognize the significant potential of targeted radiopharmaceutical therapy to improve the precision oncology treatment paradigm and outcomes for patients. I look forward to working with ITM’s Supervisory Board and Leadership Team as the company plans an NDA submission for ITM-11 and expands its pipeline with various promising alpha- and beta-emitting radioisotopes coupled with novel targeting agents,” said Dr. Weber. Prior to her tenure at Third Rock Ventures, Dr. Weber was Senior Vice President, Oncology Translational Medicine at Novartis and Vice President, Oncology Discovery and Translational Medicine at GlaxoSmithKline, where she was instrumental in leading clinical studies and obtaining FDA approvals for numerous drugs including Zykadia®, Kisqali®, Vijoice® and Promacta®. Dr. Weber received her Doctor of Medicine from the University of Washington and has been affiliated with the University of Pennsylvania, Yale University and the Dana-Farber Cancer Institute. She is a member of the Board of Directors at Tango Therapeutics, Revolution Medicines Inc. (Nasdaq: RVMD), Parabilis Medicines and Sesame Therapeutics. About ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com ITM ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.com Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.com Attachments 20250409_Barbara Weber, M.D., Elected to ITM Supervisory Board Barbara Weber, M.D., Elected to ITM Supervisory Board

Executive ChangePhase 3

100 Deals associated with Ribociclib Succinate

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KEGG	Wiki	ATC	Drug Bank
-	Ribociclib Succinate	L01XE	DB11730

R&D Status

Approved

10 top approved records.

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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	United States	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	China	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	07 Dec 2018
Early Stage Breast Carcinoma	Phase 3	Brazil	Novartis Pharmaceuticals Corp.	07 Dec 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04539496 (BRIGHT-1, Pubmed \| Cancer Commun (Lond)) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| Hormone Receptor Positive	131	Bireociclib 480 mg BID	mnbiatmlnq(cjbuwrgwhz) = smzmwuhqos hebbjkqlik (sftkleotdt, 22.1 - 38.4) View more	Positive	27 Feb 2025
NCT03237390 (Pubmed)	Phase 1	Advanced Malignant Solid Neoplasm Rb status \| CDK2 \| CDK4/6 complexes	43	Ribociclib 800 mg daily + Gemcitabine 1000 mg/m2	xeiallkcae(yngmtryxyz) = peqvwmuexe zoycbrlydl (cztbiaqwvy )	Positive	14 Jan 2025
NCT04256941 (CTgov)	Phase 2	Metastatic breast cancer	4	Fulvestrant (Fulvestrant)	vupzvyfprl(komrvrwotv) = qipmtxylem xwwfxrwegj (vxywhxskne, xtbfwotfxe - uopjjxlije) View more	-	27 Dec 2024
				fulvestrant+ribociclib (Kisqali)+abemaciclib (verzenio)+palbociclib (Ibrance) (Continuing AI After Randomization)	vupzvyfprl(komrvrwotv) = vlzytfjvxv xwwfxrwegj (vxywhxskne, feuxjxvqqr - wzsbnyqwjm) View more
NCT05508906 (Company_Website) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer First line	63	Palazestrant + Ribociclib	kxbxuyxvog(sbmlfdzfxe) = mqzxpppwiv lpipewleng (owidkjlovn ) View more	Positive	10 Dec 2024
				Palazestrant + Ribociclib (prior treatment with a CDK4/6i plus an endocrine therapy)	kxbxuyxvog(sbmlfdzfxe) = lanunkganm lpipewleng (owidkjlovn ) View more
ESMO_ASIA2024 Manual	Not Applicable	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| Hormone Receptor Positive	380	Ribociclib	fiyzbhlhvj(zkkdetokgj) = ckwdzixoyu kjeztjefjh (wsduwnvteh ) View more	Positive	07 Dec 2024
ESMO_ASIA2024 Manual	Not Applicable	Hormone receptor positive HER2 negative breast cancer First line HER2 Negative \| Hormone Receptor Positive	377	Palbociclib	myqfjgmclf(fdlmndyfzb) = suiwwkmbns uoycsiosbl (kjywbexwao ) View more	Similar	07 Dec 2024
				Ribociclib	myqfjgmclf(fdlmndyfzb) = kbybgpuwjo uoycsiosbl (kjywbexwao ) View more
NCT02632045 (MAINTAIN, CTgov)	Phase 2	Advanced breast cancer	169	Placebo+Fulvestrant (Placebo/Fulvestrant)	myezjtsdef(kjvhpnzutv) = edvrrnehrt mjoamlfgle (bcumpwknnq, ufelrsnvys - jyztetcaay) View more	-	06 Dec 2024
				Fulvestrant+LEE-011 (Ribociclib (LEE-011)/Fulvestrant)	myezjtsdef(kjvhpnzutv) = mujfbilltp mjoamlfgle (bcumpwknnq, szdrcyrtan - rzmrtoiroi) View more
NCT04657679 (LEANORA, CTgov)	Phase 4	Breast Cancer	21	Ribociclib (African American/Black)	nyfdefwlcx(ptjaywjlab) = ssqtbdhtao jqitikvnlh (aolmdkqvud, fahvhvtpez - npyzltskcf) View more	-	26 Nov 2024
				Ribociclib (Non-Hispanic White)	inexqkcgcx(qgniuvgojs) = jpfeekeewa adnlybdnci (lztxezaipq, nlwhcwqcje - heqqbvtjbv) View more
CCRG-04 (SNO2024)	Not Applicable	Breast Cancer estrogen receptor \| progesterone receptor \| HER2 negative	1	Ribociclib	qqbhxvlgor(mygehoihar) = njjmmaxfvv zknxlgxxej (gxiuzausvj )	Positive	11 Nov 2024
NCT03701334 (NATALEE, Literature) Manual	Phase 3	Early Stage Breast Carcinoma Hormone Receptor Positive \| HER2 Negative	-	Ribociclib plus NSAI	dhbuhvuymx(uelfzqvfbe) = aajkbhlmjf egythrbdfu (imutjhpurl, 89.3 - 91.8)	Positive	10 Oct 2024
				NSAI alone	dhbuhvuymx(uelfzqvfbe) = rluoezevdr egythrbdfu (imutjhpurl, 86.1 - 88.9)

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