Novartis Investigational Lung Cancer Therapy Granted FDA Breakthrough Therapy Designation
“We are pleased to announce that the US FDA granted Breakthrough Therapy Designation to capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC),” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis.
Recent research concludes that the cMET gene is an oncogenic driver,, and the investigational lung cancer therapy capmatinib has been shown to be a highly potent and selective MET inhibitor. The MET mutation is seen in an estimated 3% – 4% of all patients with NSCLC. These patients are generally older and often have a poor prognosis that can limit lung cancer treatment options[4-6]. “As we continue to reimagine medicine and place a renewed focus on the development of innovative lung cancer treatments, we look forward to working with the FDA and global health authorities to bring capmatinib to patients who currently have no available targeted therapy options,” continued Dr. Tsai.
According to FDA guidelines, treatments that receive Breakthrough Therapy Designation must target a serious or life-threatening disease and demonstrate a substantial improvement over existing therapies on one or more significant preliminary research endpoints. The FDA granted Breakthrough Therapy Designation for capmatinib based on positive primary results from the GEOMETRY mono-1 study presented at the 2019 meeting of American Society of Clinical Oncology. Please click link for complete study results [http://bit.ly/2L7L3ta]
Capmatinib (INC280) is an investigational, oral, highly potent and selective MET inhibitor licensed to Novartis by Incyte Corporation in 2009. Under the Agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.
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