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Malaysian Reserve
24-04-2025
- Business
- Malaysian Reserve
DelveInsight's Strategic Support to a Biopharma Leader in NSCLC Epidemiology Forecasting up to 2034, Segmented by Biomarker Types
In the rapidly evolving landscape of oncology, precision is the cornerstone of progress. A leading biopharmaceutical company specializing in non-small cell lung cancer (NSCLC) turned to DelveInsight, a trusted name in healthcare analytics, for a comprehensive epidemiology forecasting analysis of NSCLC segmented by genetic biomarkers. With ambitious goals to refine their drug development strategy, pinpoint target patient populations, and streamline market access, the client faced complex challenges. LAS VEGAS, April 24, 2025 /PRNewswire/ — DelveInsight's data-driven approach not only illuminated the path forward but also positioned the client as a frontrunner in biomarker-driven NSCLC therapies. This case study showcases how DelveInsight's expertise in epidemiology forecasting delivered actionable insights, driving strategic success in a competitive market. Interested in getting the patient-based market forecasting report on the NSCLC market? Download sample Challenges Faced by the Client in NSCLC Epidemiology Forecasting: The client, a prominent player in oncology, sought to advance their pipeline of NSCLC therapies by leveraging precise epidemiological data. They required detailed biomarker-specific segmentation to strengthen their drug development strategy, accurately define target patient populations, and streamline market access planning. With biomarker-driven therapies becoming central to oncology, the client sought a comprehensive analysis of key genetic mutations and protein expressions, including PD-L1, KRAS, EGFR, BRAF, NTRK, MET, HER2, ROS1, and TIGIT. They also needed granular, country-specific NSCLC epidemiological data forecasts across the 7MM: the United States, EU4 (Germany, France, Italy, Spain), the UK, and Japan, to evaluate regional patient trends and support commercial strategy development. The client requested long-term historical and forecast data spanning 2020 to 2034 to ensure alignment with clinical timelines and launch objectives. A core focus was uncovering opportunities in underexplored areas—specifically, rare biomarkers and difficult-to-treat gene fusions representing unmet needs in the current pharmaceutical landscape. Explore detailed market insights, biomarker-driven epidemiology, and future forecasts – Click here to learn more. DelveInsight's Strategic Methodology for NSCLC Epidemiology and Biomarker Forecasting To help the client, DelveInsight adopted a multi-dimensional, data-driven approach to forecast the NSCLC epidemiology and its evolving biomarker landscape. This methodology integrated: Real-World Evidence: Sourced from healthcare databases and patient registries. Country-Specific Data: Leveraged cancer registries and regional health reports across the 7MM. Scientific Literature: Analyzed peer-reviewed publications and meta-analysis clinical studies. Primary Research: Conducted interviews with key opinion leaders (KOLs) to validate findings and capture nuanced insights. This robust data foundation enabled DelveInsight to build a dynamic epidemiology model tailored to NSCLC and its biomarker complexities. Granular NSCLC Epidemiology Segmentation and Forecasting As requested by the client, DelveInsight's analysis provided a comprehensive and granular perspective on the epidemiological landscape of non-small cell lung cancer across major markets. In 2024, the United States reported approximately 204K incident cases of NSCLC, with a higher incidence observed in men compared to women. A key trend was the high concentration of NSCLC cases in individuals aged 65 and older, highlighting the increasing impact of the disease on aging populations. When assessing histological subtypes, adenocarcinoma remained the most common, accounting for approximately 59% of cases, followed by squamous cell carcinoma and large cell carcinoma. A key focus of the analysis was biomarker-driven segmentation, which played a pivotal role in personalizing treatment approaches. PD-L1 emerged as the most prevalent biomarker, reaffirming its central role in guiding immunotherapy. Among genetic alterations, KRAS mutations were significant, and data on the populations of KRAS G12C mutations and non-G12C KRAS variants were presented to the client. Other notable molecular alterations in NSCLC include: EGFR and BRAF mutations – Each observed in a small but significant portion of cases NTRK fusions – Found in a limited subset of patients MET-related alterations – Including exon 14 skipping mutations, gene amplifications, and c-MET overexpression Emerging biomarkers – Such as HER2 mutations/amplifications, ROS1 rearrangements, and TIGIT expression, all drawing growing interest in clinical research and targeted therapy development The study also presented insights into stage-wise epidemiological distribution, offering strategic perspectives for therapeutic interventions. Early-stage NSCLC (Stages I & II) represented approximately 35% of diagnosed cases, indicating growing potential for adjuvant and neoadjuvant treatment approaches. Meanwhile, advanced-stage disease (Stages IIIB & IV) accounted for nearly 50%, aligning with the current focus of most targeted therapies and immunotherapy regimens. DelveInsight's robust epidemiological segmentation enabled a deeper understanding of the NSCLC burden, unlocking opportunities for precision medicine, clinical development, and market strategy. Custom Non-Small Cell Lung Cancer Evergreen Forecasting Model (2020–2034) DelveInsight's Custom Forecast Model (2025-2034) provided the client with a dynamic, evergreen tool to navigate the rapidly evolving landscape of non-small cell lung cancer. This model projected NSCLC incidence trends while adjusting for a variety of influencing factors, ensuring the client had accurate insights for strategic decision-making. Key Factors Influencing the Forecast: Demographic Shifts: The model accounted for the aging population and changes in smoking prevalence, both of which significantly affect NSCLC incidence. Advancements in Genetic Testing & Screening: With the increased adoption of biomarker testing across countries, the model projected how genetic advancements could impact disease identification and treatment. Country-Specific Biomarker Testing Trends: The extent to which various countries have integrated or recommended biomarker testing played a crucial role in forecasting NSCLC trends. Evolving Treatment Paradigms: The rapid introduction of new targeted therapies and immunotherapies reshaped treatment options, and the model accounted for these changes to provide forward-looking insights. Strategic Impact & Key Insights By leveraging DelveInsight's biomarker-driven epidemiology forecasting, the client gained essential insights that significantly influenced their strategic decisions: Optimizing Clinical Trial Planning: The client was able to identify specific biomarker-driven patient populations as key targets for clinical trials, ensuring focused and efficient research efforts. Strengthening Market Expansion Strategy: By prioritizing countries based on biomarker prevalence trends, the client was able to tailor their market entry strategy, enhancing the chances of success in select regions. Enhancing Regulatory & Commercial Decision-Making: The detailed segmentation data supported discussions around label expansion, payer negotiations, and pricing strategies, providing a competitive edge in the market. Impact & Results after DelveInsight's Help Through DelveInsight's comprehensive NSCLC epidemiology study, the client saw tangible business value in several key areas: Enhanced Drug Development Strategy: The company optimized patient enrollment criteria for its NSCLC biomarker-driven clinical trials, ensuring that research focused on the most relevant populations. Informed Market Access Plans: The forecasting data helped shape targeted commercialization strategies for different geographies, allowing the client to enter high-opportunity markets more effectively. Competitive Positioning: The client gained a first-mover advantage in biomarker-driven NSCLC therapies, positioning themselves as leaders in the evolving precision oncology market. According to DelveInsight's NSCLC market report, the value of the NSCLC market in the 7MM was approximately USD 30 billion in 2024, with substantial growth projected through 2034. The treatment landscape is evolving rapidly, led by biomarker-driven therapies and the rising adoption of PD-L1-targeting immunotherapies. Merck's KEYTRUDA has emerged as the gold standard for first-line treatment, particularly when combined with platinum-based chemotherapy for patients without actionable mutations. Leading companies are leveraging DelveInsight's biomarker-specific epidemiology forecasting to gain deep insights into disease segmentation, long-term incidence trends, and biomarker prevalence. These insights enable companies to refine their R&D and commercialization strategies, driving data-driven decisions for better patient outcomes and sustained market growth. Key players in the NSCLC market include AstraZeneca, Boehringer Ingelheim, Pfizer, Takeda, Johnson & Johnson Innovative Medicine, Eli Lilly and Company, Merck, Bristol-Myers Squibb, Roche, Shanghai Henlius Biotech, AbbVie, Daiichi Sankyo, Nuvation Bio, PDC*line Pharma, Moderna Therapeutics, GSK, Gilead Sciences, BieGene, Nuvalent, and emerging biotechs like Nuvalent, Moderna, and BeiGene, with pipelines targeting KRAS, MET, EGFR, NTRK, TIGIT, and more. Driving Business Success through DelnveInsight's Data-Driven Insights DelveInsight's NSCLC biomarker-driven epidemiology forecasting empowered the client to navigate a complex and competitive market confidently. With granular, actionable insights, DelveInsight not only refined the client's drug development and commercialization strategies but also positioned them as a leader in precision oncology. This case study highlights how DelveInsight's data-driven foresight transformed challenges into strategic opportunities, driving both business success and improved patient outcomes in the NSCLC market. DelveInsight continues to lead the way in offering innovative solutions, providing a range of services that empower clients to make informed decisions in the ever-evolving healthcare landscape. Here are some of the other key services that DelveInsight excels in and pioneers: Competitive Intelligence Services Tailored to Oncology Domain: DelveInsight's competitive intelligence services deliver real-time, precise insights across therapeutic domains, with oncology being one of our key areas of expertise. We provide in-depth analysis of advancements across both prevalent and rare conditions, including NSCLC, Pancreatic Cancer, Breast Cancer, and Acute Myeloid Leukemia, among others. Our services track competitor pipelines, clinical trial progress, regulatory shifts, and patent landscapes, offering a comprehensive view of the evolving oncology market. By leveraging these insights, stakeholders can identify emerging threats, seize growth opportunities, and craft strategic moves to stay ahead in this dynamic space. Market Size and Share Assessment Services: DelveInsight provides a 360-degree market landscape analysis, delivering 10-year epidemiology-driven market forecasts. Our expertise offers precise insights into emerging therapies' current and projected market share, helping stakeholders navigate evolving treatment landscapes. By integrating emerging trends, competitive dynamics, and unmet needs, we empower businesses to craft data-driven strategies and identify lucrative opportunities. Whether it's pipeline analysis, pricing strategies, or competitive benchmarking, DelveInsight delivers actionable intelligence tailored to your strategic goals. R&D Analysis: DelveInsight's skilled research and development analyst specializes in the complexities of different indications, offering essential insights and advice to clients aiming to advance in research and development. They utilize a methodical assessment approach, aligned with industry norms, to track the progress of each drug in both pre-clinical and clinical stages. DelveInsight's comprehensive reports are crafted to reduce uncertainties and highlight overlooked areas, providing organizations with timely and strategic intelligence. Portfolio Management: DelveInsight's Portfolio Management services help clients assess competencies, leverage strengths, and align strategic priorities. Our structured approach identifies market needs, optimizes resources, and enhances portfolio value. With comprehensive market intelligence, we empower organizations to make informed, data-driven decisions, minimizing risks and maximizing long-term impact for both customers and the company. Why Choose DelveInsight? DelveInsight's Market Assessment Services provide data-driven insights and competitive intelligence to help pharmaceutical companies navigate evolving market landscapes. With 10-year forecasts, drug uptake analysis, competitive benchmarking, and customized market evaluations, we deliver precise projections for both emerging and established markets. Our expertise in epidemiology modeling, primary intelligence, and data analytics ensures clients gain a clear, strategic understanding of their therapy's potential and competitive positioning. Covering the 7MM region and beyond, DelveInsight equips stakeholders with actionable intelligence to drive informed decision-making and commercial success. Get in touch today to leverage our expertise and stay ahead in the competitive market! Contact us for a personalized consultation. Contact UsShruti Thakurinfo@ Logo: View original content:
Yahoo
24-04-2025
- Business
- Yahoo
A Success Story - DelveInsight's Strategic Support to a Biopharma Leader in NSCLC Epidemiology Forecasting up to 2034, Segmented by Biomarker Types
In the rapidly evolving landscape of oncology, precision is the cornerstone of progress. A leading biopharmaceutical company specializing in non-small cell lung cancer (NSCLC) turned to DelveInsight, a trusted name in healthcare analytics, for a comprehensive epidemiology forecasting analysis of NSCLC segmented by genetic biomarkers. With ambitious goals to refine their drug development strategy, pinpoint target patient populations, and streamline market access, the client faced complex challenges. LAS VEGAS, April 24, 2025 /PRNewswire/ -- DelveInsight's data-driven approach not only illuminated the path forward but also positioned the client as a frontrunner in biomarker-driven NSCLC therapies. This case study showcases how DelveInsight's expertise in epidemiology forecasting delivered actionable insights, driving strategic success in a competitive market. Interested in getting the patient-based market forecasting report on the NSCLC market? Download sample Challenges Faced by the Client in NSCLC Epidemiology Forecasting: The client, a prominent player in oncology, sought to advance their pipeline of NSCLC therapies by leveraging precise epidemiological data. They required detailed biomarker-specific segmentation to strengthen their drug development strategy, accurately define target patient populations, and streamline market access planning. With biomarker-driven therapies becoming central to oncology, the client sought a comprehensive analysis of key genetic mutations and protein expressions, including PD-L1, KRAS, EGFR, BRAF, NTRK, MET, HER2, ROS1, and TIGIT. They also needed granular, country-specific NSCLC epidemiological data forecasts across the 7MM: the United States, EU4 (Germany, France, Italy, Spain), the UK, and Japan, to evaluate regional patient trends and support commercial strategy development. The client requested long-term historical and forecast data spanning 2020 to 2034 to ensure alignment with clinical timelines and launch objectives. A core focus was uncovering opportunities in underexplored areas—specifically, rare biomarkers and difficult-to-treat gene fusions representing unmet needs in the current pharmaceutical landscape. Explore detailed market insights, biomarker-driven epidemiology, and future forecasts – Click here to learn more. DelveInsight's Strategic Methodology for NSCLC Epidemiology and Biomarker Forecasting To help the client, DelveInsight adopted a multi-dimensional, data-driven approach to forecast the NSCLC epidemiology and its evolving biomarker landscape. This methodology integrated: Real-World Evidence: Sourced from healthcare databases and patient registries. Country-Specific Data: Leveraged cancer registries and regional health reports across the 7MM. Scientific Literature: Analyzed peer-reviewed publications and meta-analysis clinical studies. Primary Research: Conducted interviews with key opinion leaders (KOLs) to validate findings and capture nuanced insights. This robust data foundation enabled DelveInsight to build a dynamic epidemiology model tailored to NSCLC and its biomarker complexities. Granular NSCLC Epidemiology Segmentation and Forecasting As requested by the client, DelveInsight's analysis provided a comprehensive and granular perspective on the epidemiological landscape of non-small cell lung cancer across major markets. In 2024, the United States reported approximately 204K incident cases of NSCLC, with a higher incidence observed in men compared to women. A key trend was the high concentration of NSCLC cases in individuals aged 65 and older, highlighting the increasing impact of the disease on aging populations. When assessing histological subtypes, adenocarcinoma remained the most common, accounting for approximately 59% of cases, followed by squamous cell carcinoma and large cell carcinoma. A key focus of the analysis was biomarker-driven segmentation, which played a pivotal role in personalizing treatment approaches. PD-L1 emerged as the most prevalent biomarker, reaffirming its central role in guiding immunotherapy. Among genetic alterations, KRAS mutations were significant, and data on the populations of KRAS G12C mutations and non-G12C KRAS variants were presented to the client. Other notable molecular alterations in NSCLC include: EGFR and BRAF mutations – Each observed in a small but significant portion of cases NTRK fusions – Found in a limited subset of patients MET-related alterations – Including exon 14 skipping mutations, gene amplifications, and c-MET overexpression Emerging biomarkers – Such as HER2 mutations/amplifications, ROS1 rearrangements, and TIGIT expression, all drawing growing interest in clinical research and targeted therapy development The study also presented insights into stage-wise epidemiological distribution, offering strategic perspectives for therapeutic interventions. Early-stage NSCLC (Stages I & II) represented approximately 35% of diagnosed cases, indicating growing potential for adjuvant and neoadjuvant treatment approaches. Meanwhile, advanced-stage disease (Stages IIIB & IV) accounted for nearly 50%, aligning with the current focus of most targeted therapies and immunotherapy regimens. DelveInsight's robust epidemiological segmentation enabled a deeper understanding of the NSCLC burden, unlocking opportunities for precision medicine, clinical development, and market strategy. Custom Non-Small Cell Lung Cancer Evergreen Forecasting Model (2020–2034) DelveInsight's Custom Forecast Model (2025-2034) provided the client with a dynamic, evergreen tool to navigate the rapidly evolving landscape of non-small cell lung cancer. This model projected NSCLC incidence trends while adjusting for a variety of influencing factors, ensuring the client had accurate insights for strategic decision-making. Key Factors Influencing the Forecast: Demographic Shifts: The model accounted for the aging population and changes in smoking prevalence, both of which significantly affect NSCLC incidence. Advancements in Genetic Testing & Screening: With the increased adoption of biomarker testing across countries, the model projected how genetic advancements could impact disease identification and treatment. Country-Specific Biomarker Testing Trends: The extent to which various countries have integrated or recommended biomarker testing played a crucial role in forecasting NSCLC trends. Evolving Treatment Paradigms: The rapid introduction of new targeted therapies and immunotherapies reshaped treatment options, and the model accounted for these changes to provide forward-looking insights. Strategic Impact & Key Insights By leveraging DelveInsight's biomarker-driven epidemiology forecasting, the client gained essential insights that significantly influenced their strategic decisions: Optimizing Clinical Trial Planning: The client was able to identify specific biomarker-driven patient populations as key targets for clinical trials, ensuring focused and efficient research efforts. Strengthening Market Expansion Strategy: By prioritizing countries based on biomarker prevalence trends, the client was able to tailor their market entry strategy, enhancing the chances of success in select regions. Enhancing Regulatory & Commercial Decision-Making: The detailed segmentation data supported discussions around label expansion, payer negotiations, and pricing strategies, providing a competitive edge in the market. Impact & Results after DelveInsight's Help Through DelveInsight's comprehensive NSCLC epidemiology study, the client saw tangible business value in several key areas: Enhanced Drug Development Strategy: The company optimized patient enrollment criteria for its NSCLC biomarker-driven clinical trials, ensuring that research focused on the most relevant populations. Informed Market Access Plans: The forecasting data helped shape targeted commercialization strategies for different geographies, allowing the client to enter high-opportunity markets more effectively. Competitive Positioning: The client gained a first-mover advantage in biomarker-driven NSCLC therapies, positioning themselves as leaders in the evolving precision oncology market. According to DelveInsight's NSCLC market report, the value of the NSCLC market in the 7MM was approximately USD 30 billion in 2024, with substantial growth projected through 2034. The treatment landscape is evolving rapidly, led by biomarker-driven therapies and the rising adoption of PD-L1-targeting immunotherapies. Merck's KEYTRUDA has emerged as the gold standard for first-line treatment, particularly when combined with platinum-based chemotherapy for patients without actionable mutations. Leading companies are leveraging DelveInsight's biomarker-specific epidemiology forecasting to gain deep insights into disease segmentation, long-term incidence trends, and biomarker prevalence. These insights enable companies to refine their R&D and commercialization strategies, driving data-driven decisions for better patient outcomes and sustained market growth. Key players in the NSCLC market include AstraZeneca, Boehringer Ingelheim, Pfizer, Takeda, Johnson & Johnson Innovative Medicine, Eli Lilly and Company, Merck, Bristol-Myers Squibb, Roche, Shanghai Henlius Biotech, AbbVie, Daiichi Sankyo, Nuvation Bio, PDC*line Pharma, Moderna Therapeutics, GSK, Gilead Sciences, BieGene, Nuvalent, and emerging biotechs like Nuvalent, Moderna, and BeiGene, with pipelines targeting KRAS, MET, EGFR, NTRK, TIGIT, and more. Driving Business Success through DelnveInsight's Data-Driven Insights DelveInsight's NSCLC biomarker-driven epidemiology forecasting empowered the client to navigate a complex and competitive market confidently. With granular, actionable insights, DelveInsight not only refined the client's drug development and commercialization strategies but also positioned them as a leader in precision oncology. This case study highlights how DelveInsight's data-driven foresight transformed challenges into strategic opportunities, driving both business success and improved patient outcomes in the NSCLC market. DelveInsight continues to lead the way in offering innovative solutions, providing a range of services that empower clients to make informed decisions in the ever-evolving healthcare landscape. Here are some of the other key services that DelveInsight excels in and pioneers: Competitive Intelligence Services Tailored to Oncology Domain: DelveInsight's competitive intelligence services deliver real-time, precise insights across therapeutic domains, with oncology being one of our key areas of expertise. We provide in-depth analysis of advancements across both prevalent and rare conditions, including NSCLC, Pancreatic Cancer, Breast Cancer, and Acute Myeloid Leukemia, among others. Our services track competitor pipelines, clinical trial progress, regulatory shifts, and patent landscapes, offering a comprehensive view of the evolving oncology market. By leveraging these insights, stakeholders can identify emerging threats, seize growth opportunities, and craft strategic moves to stay ahead in this dynamic space. Market Size and Share Assessment Services: DelveInsight provides a 360-degree market landscape analysis, delivering 10-year epidemiology-driven market forecasts. Our expertise offers precise insights into emerging therapies' current and projected market share, helping stakeholders navigate evolving treatment landscapes. By integrating emerging trends, competitive dynamics, and unmet needs, we empower businesses to craft data-driven strategies and identify lucrative opportunities. Whether it's pipeline analysis, pricing strategies, or competitive benchmarking, DelveInsight delivers actionable intelligence tailored to your strategic goals. R&D Analysis: DelveInsight's skilled research and development analyst specializes in the complexities of different indications, offering essential insights and advice to clients aiming to advance in research and development. They utilize a methodical assessment approach, aligned with industry norms, to track the progress of each drug in both pre-clinical and clinical stages. DelveInsight's comprehensive reports are crafted to reduce uncertainties and highlight overlooked areas, providing organizations with timely and strategic intelligence. Portfolio Management: DelveInsight's Portfolio Management services help clients assess competencies, leverage strengths, and align strategic priorities. Our structured approach identifies market needs, optimizes resources, and enhances portfolio value. With comprehensive market intelligence, we empower organizations to make informed, data-driven decisions, minimizing risks and maximizing long-term impact for both customers and the company. Why Choose DelveInsight? DelveInsight's Market Assessment Services provide data-driven insights and competitive intelligence to help pharmaceutical companies navigate evolving market landscapes. With 10-year forecasts, drug uptake analysis, competitive benchmarking, and customized market evaluations, we deliver precise projections for both emerging and established markets. Our expertise in epidemiology modeling, primary intelligence, and data analytics ensures clients gain a clear, strategic understanding of their therapy's potential and competitive positioning. Covering the 7MM region and beyond, DelveInsight equips stakeholders with actionable intelligence to drive informed decision-making and commercial success. Get in touch today to leverage our expertise and stay ahead in the competitive market! Contact us for a personalized consultation. Contact UsShruti Thakurinfo@ Logo: View original content: SOURCE DelveInsight Business Research, LLP Sign in to access your portfolio
Yahoo
21-04-2025
- Business
- Yahoo
Zai Lab Announces Acceptance of Supplemental New Drug Application for Repotrectinib for Patients with NTRK-Positive Solid Tumors
SHANGHAI & CAMBRIDGE, Mass., April 21, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China's National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The application is intended for patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options. "NTRK fusion-positive tumors represent a significant therapeutic challenge, particularly in the setting of acquired resistance to existing TRK tyrosine kinase inhibitors (TKIs)," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "There are no approved treatments for NTRK-positive cancers for both TKI-naïve and TKI-pretreated patients in China. Repotrectinib has the potential to become a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors in both settings." In February 2025, China's NMPA granted priority review to repotrectinib for the treatment of adult patients with advanced solid tumors that have an NTRK gene fusion. About Repotrectinib Repotrectinib is a next-generation tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers. Patients with solid tumors, including NSCLC, harboring ROS1 and NTRK gene fusions treated with approved targeted therapies often develop resistance mutations that limit binding of these drugs to their target. Ultimately, this leads to shortened duration of response and tumor progression. Repotrectinib is the first next-generation ROS1 and TRK TKI uniquely designed to improve durability of benefit, including in the brain, and to address acquired resistance. In June 2024, AUGTYRO (repotrectinib) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. In May 2024, AUGTYRO was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC). It was approved by the FDA for this indication in November 2023. Zai Lab has an exclusive license agreement with Turning Point Therapeutics, Inc. (a Bristol Myers Squibb company) to develop and commercialize AUGTYRO in Greater China (mainland China, Hong Kong, Taiwan, and Macau, collectively). About NTRK-Positive Solid Tumors NTRK-positive advanced malignancies are life-threatening with poor prognoses and represent an area of significant unmet medical need in adult and pediatric patients. Existing targeted therapies have demonstrated clinical benefits but are limited by the duration of response due to the emergence of acquired resistance mutations.1 In China, there was no approved treatment option for NTRK-positive cancers that was studied in both TKI-naïve and TKI-pretreated patients across solid tumors. 1 Harada G, Santini FC, Wilhelm C, Drilon A, et al. NTRK fusions in lung cancer: From biology to therapy. Lung Cancer. 2021;161:108-113. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit or follow us at Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements relating to our prospects and plans for developing and commercializing repotrectinib in Greater China, the potential benefits of repotrectinib, and the potential treatment of NTRK-positive solid tumors. These forward-looking statements may contain words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would," and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business decisions, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC's website at View source version on Contacts For more information, please contact:Investor Relations: Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 / Media: Shaun Maccoun / Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 /
Business Wire
21-04-2025
- Business
- Business Wire
Zai Lab Announces Acceptance of Supplemental New Drug Application for Repotrectinib for Patients with NTRK -Positive Solid Tumors
SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China's National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The application is intended for patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options. Repotrectinib has the potential to become a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors in both settings. Share ' NTRK fusion-positive tumors represent a significant therapeutic challenge, particularly in the setting of acquired resistance to existing TRK tyrosine kinase inhibitors (TKIs),' said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. 'There are no approved treatments for NTRK -positive cancers for both TKI-naïve and TKI-pretreated patients in China. Repotrectinib has the potential to become a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors in both settings.' In February 2025, China's NMPA granted priority review to repotrectinib for the treatment of adult patients with advanced solid tumors that have an NTRK gene fusion. About Repotrectinib Repotrectinib is a next-generation tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers. Patients with solid tumors, including NSCLC, harboring ROS1 and NTRK gene fusions treated with approved targeted therapies often develop resistance mutations that limit binding of these drugs to their target. Ultimately, this leads to shortened duration of response and tumor progression. Repotrectinib is the first next-generation ROS1 and TRK TKI uniquely designed to improve durability of benefit, including in the brain, and to address acquired resistance. In June 2024, AUGTYRO (repotrectinib) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. In May 2024, AUGTYRO was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small-cell lung cancer (NSCLC). It was approved by the FDA for this indication in November 2023. Zai Lab has an exclusive license agreement with Turning Point Therapeutics, Inc. (a Bristol Myers Squibb company) to develop and commercialize AUGTYRO in Greater China (mainland China, Hong Kong, Taiwan, and Macau, collectively). About NTRK -Positive Solid Tumors NTRK -positive advanced malignancies are life-threatening with poor prognoses and represent an area of significant unmet medical need in adult and pediatric patients. Existing targeted therapies have demonstrated clinical benefits but are limited by the duration of response due to the emergence of acquired resistance mutations. 1 In China, there was no approved treatment option for NTRK -positive cancers that was studied in both TKI-naïve and TKI-pretreated patients across solid tumors. 1 Harada G, Santini FC, Wilhelm C, Drilon A, et al. NTRK fusions in lung cancer: From biology to therapy. Lung Cancer. 2021;161:108-113. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit or follow us at Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements relating to our prospects and plans for developing and commercializing repotrectinib in Greater China, the potential benefits of repotrectinib, and the potential treatment of NTRK -positive solid tumors. These forward-looking statements may contain words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would,' and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business decisions, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission. 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10-04-2025
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U.S. FDA Grants Full Approval of VITRAKVI® (larotrectinib) for Adult and Pediatric Patients with NTRK Gene Fusion-Positive Solid Tumors
VITRAKVI® is now fully approved for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation that have spread or who aren't eligible for surgery, and have no satisfactory alternative treatments or that have progressed following treatment, following accelerated approval previously granted in this indication The full approval of VITRAKVI is based on the results of confirmatory trials that support VITRAKVI as a potential new standard of care treatment option for NTRK gene fusion-positive tumors in adult and pediatric patients VITRAKVI is a first-in-class treatment exclusively designed to inhibit TRK WHIPPANY, N.J., April 10, 2025--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted full approval for VITRAKVI® (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.1 VITRAKVI has demonstrated clinically meaningful and durable responses across a range of NTRK fusion-positive solid tumors. VITRAKVI was first granted accelerated approval by FDA in November 2018.1 "This first full approval of an NTRK inhibitor by the FDA represents the culmination of research and dedication by the Bayer team," said Chandra Goda, Executive Director, U.S. VITRAKVI Brand Lead. "We are proud to deliver on our promise for patients with this significant step forward, providing a treatment option for pediatric and adult patients living with NTRK gene fusion-positive cancers. This milestone reinforces Bayer's commitment to delivering innovative solutions that address the unique needs of patients and their families." "The full approval of VITRAKVI by the FDA is a welcome step forward, solidifying its place as a treatment option for patients with NTRK gene fusion-positive cancers," said Andrea Ferris, President and CEO, LUNGevity Foundation. "This milestone not only benefits patients today but also paves the way for further advancements in NTRK gene therapies in the future." This approval is based on data from three multicenter, open-label, single-arm clinical trials: LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431). This analysis included pediatric and adult patients with unresectable or metastatic solid tumors with an NTRK gene fusion (n=339). All patients were required to have progressed following systemic therapy for their disease, if available, or would have required surgery with significant morbidity for locally advanced disease.1 The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as determined by a blinded independent review committee (BIRC) according to RECIST v1.1. 1 Safety was assessed in 444 patients across the three trials.1 Pooled efficacy results showed an ORR of 60% (95% CI: 55%-65%) with a complete response (CR) rate of 24% and a partial response (PR) rate of 36%.1 Five percent of patients with complete response were pathological complete response. Patients undergoing a surgical resection whose post-operative pathologic assessment showed no viable tumor cells and negative margins were pathological complete responders provided that no other sites of disease were present. Median DOR was 43.3 months (95% CI: 32.5-NE (not evaluable)).1 The most common (≥20%) adverse reactions, including laboratory abnormalities, with VITRAKVI were increased AST, increased ALT, anemia, hypoalbuminemia, musculoskeletal pain, increased alkaline phosphatase, leukopenia, lymphopenia, neutropenia, hypocalcemia, fatigue, vomiting, cough, constipation, pyrexia, diarrhea, nausea, abdominal pain, dizziness, and rash.1 Serious adverse events (AEs) reported included central nervous system (CNS) problems, bone fractures and liver problems.1 About VITRAKVI® (larotrectinib) VITRAKVI, a first-in-class oral TRK inhibitor, was exclusively designed to inhibit against the TRK family of proteins (TRKA, TRKB, and TRKC). In in vitro and in vivo tumor models, VITRAKVI demonstrated anti-tumor activity in cells with constitutive activation of TRK proteins resulting from gene fusions, deletion of a protein regulatory domain, or in cells with TRK protein overexpression. Constitutively-activated chimeric TRK fusion proteins can act as an oncogenic driver, promoting cell proliferation and survival in tumor cell lines.1 In the U.S., VITRAKVI is approved for the treatment of adult and pediatric patients with solid tumors that display a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.1 Following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019, Bayer has obtained the exclusive licensing rights for the global development and commercialization, including in the U.S., for VITRAKVI. INDICATION VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. IMPORTANT SAFETY INFORMATION Warnings and Precautions Central Nervous System Effects: Central nervous system (CNS) adverse reactions occurred in patients receiving VITRAKVI, including dizziness, cognitive impairment, mood disorders, and sleep patients who received VITRAKVI, all grades CNS effects including cognitive impairment, mood disorders, dizziness and sleep disorders were observed in 40.3% with Grades 3-4 in 3.8% of impairment occurred in 11% of patients. The median time to onset of cognitive impairment was 6 months (range: 2 days to 56 months). Cognitive impairment occurring in ≥ 1% of patients included memory impairment (4.1%), disturbance in attention (3.6%), confusional state (2.3%), cognitive disorder (1.6%), delirium (1.4%), and hallucination (1.1%). Grade 3 cognitive adverse reactions occurred in 1.8% of patients and Grade 4 cognitive adverse reactions in 0.2% of patients. Among the 49 patients with cognitive impairment, 6% required a dose modification and 18% required dose disorders occurred in 14% of patients. The median time to onset of mood disorders was 3.3 months (range: 1 day to 65 months). Mood disorders occurring in ≥1% of patients included anxiety (5%), agitation (3.2%), depression (3.2%), irritability (2.3%), and restlessness (1.1%). Grade 3 mood disorders occurred in 0.9% of patients. Among the 63 patients who experienced mood disorders, no patient required a dose modification, and 1.6% required dose occurred in 22% of patients, and Grade 3 dizziness occurred in 0.9% of patients. Among the 96 patients who experienced dizziness, 6% of patients required a dose modification and 5% required dose disturbances occurred in 12% of patients. Sleep disturbances included insomnia (9%), somnolence (3.4%), and sleep disorder (0.5%). Grade 3 sleep disturbances occurred in 0.2% of patients. Among the 54 patients who experienced sleep disturbances, no patient required a dose modification and 3.7% required dose patients and caretakers of these risks with VITRAKVI. Advise patients not to drive or operate hazardous machinery if they are experiencing neurologic adverse reactions. Withhold or permanently discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI dosage when resumed. Skeletal Fractures: Skeletal fractures can occur in patients taking 444 patients who received VITRAKVI across clinical trials, fractures occurred in 7% of patients; 6% of 290 adult patients and 10% of 154 pediatric patients. Median time to first fracture was 13 months (range 27 days to 73 months) in patients followed per fracture. The most common fractures were of the rib (1.4%), fibula, foot or wrist (0.7% each). Most fractures were associated with minimal or moderate trauma. Some fractures were associated with radiologic abnormalities suggestive of local tumor involvement. VITRAKVI treatment was interrupted due to fracture in 1.4% evaluate patients with signs or symptoms of potential fracture (e.g., pain, changes in mobility, deformity). There are no data on the effects of VITRAKVI on healing of known fractures or risk of future fractures. Hepatotoxicity: Hepatotoxicity including drug induced liver injury (DILI) has occurred in patients taking patients who received VITRAKVI (n=444), increased AST of any grade occurred in 62% of patients and increased ALT of any grade occurred in 61%. Grade 3-4 increased AST or ALT occurred in 7% and 8% of patients, respectively. The median time to onset of increased AST was 1.9 months (range: 4 days to 3.8 years). The median time to onset of increased ALT was 1.9 months (range: 1 day to 4.9 years). Increased AST and ALT leading to dose modifications occurred in 1.6% and 3.2% of patients, respectively. Increased AST or ALT led to permanent discontinuation in 4 (0.9%) have been reports from clinical studies and postmarketing cases of Grade ≥ 2 increases in ALT and/or AST with increases in bilirubin ≥ 2 x liver function tests (ALT, AST, ALP and bilirubin) before initiation of VITRAKVI and monitor every 2 weeks during the first 2 months of treatment, then monthly thereafter, or more frequently following the occurrence of Grade 2 or greater AST or ALT elevation. Temporarily withhold, reduce the dose, or permanently discontinue VITRAKVI based on severity. Embryo-Fetal Toxicity: VITRAKVI can cause fetal harm when administered to a pregnant woman. Larotrectinib resulted in malformations in rats and rabbits at maternal exposures that were approximately 11- and 0.7-times, respectively, those observed at the clinical dose of 100 mg twice daily. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment and for 1 week after the last dose of VITRAKVI. Adverse Reactions The most common adverse reactions (≥20%), including laboratory abnormalities, were: increased AST (62%), increased ALT (61%), anemia (45%), hypoalbuminemia (44%), musculoskeletal pain (41%), increased alkaline phosphatase (40%), leukopenia (37%), lymphopenia (35%), neutropenia (34%), hypocalcemia (32%), fatigue (31%), vomiting (30%), cough (29%), constipation (27%), pyrexia (26%), diarrhea (26%), nausea (25%), abdominal pain (24%), dizziness (22%), and rash (21%). Drug Interactions Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors (including grapefruit or grapefruit juice), strong CYP3A4 inducers (including St. John's wort), or sensitive CYP3A4 substrates. If coadministration of strong CYP3A4 inhibitors or inducers cannot be avoided, modify the VITRAKVI dose as recommended. If coadministration of sensitive CYP3A4 substrates cannot be avoided, monitor patients for increased adverse reactions of these drugs. For coadministration with moderate CYP3A4 inhibitors, monitor for adverse reactions more frequently and reduce the dosage based on severity. For coadministration with moderate CYP3A4 inducers, modify dose as recommended. Use in Specific Populations Lactation: Advise women not to breastfeed during treatment with VITRAKVI and for 1 week after the last dose. Please see the full Prescribing Information for VITRAKVI® (larotrectinib). About TRK Fusion Cancer2 TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signaling cascade. These TRK fusion proteins act as oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer, regardless of where it originates in the body. TRK fusion cancer is not limited to certain types of tissues and can occur in any part of the body. TRK fusion is present in many tumors with varying frequency, including lung, thyroid, gastrointestinal cancers (colon, cholangiocarcinoma, pancreatic and appendiceal), sarcoma, CNS cancers (glioma and glioblastoma), salivary gland cancers (mammary analogue secretory carcinoma) and pediatric cancers (infantile fibrosarcoma and soft tissue sarcoma).2 TRK fusion cancer is diagnosed through the identification of NTRK gene fusions using specific tests, including those that employ next-generation sequencing (NGS) and fluorescence in situ hybridization (FISH).2 About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to © 2025 Bayer BAYER, the Bayer Cross and VITRAKVI are registered trademarks of Bayer. Find more information at Our online press service is just a click away: Follow us on Facebook: Follow us on X: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References VITRAKVI® (larotrectinib) [Package Insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, April 2025. Manea CA, Badiu DC, Ploscaru IC, et al. A review of NTRK fusions in cancer. Ann Med Surg. 2022;79:103893. View source version on Contacts Silvia Grosso, Tel +1 973 270 6828Email: Polina Miklush, Tel + 862.431.8817Email: Sign in to access your portfolio
