After FDA granted breakthrough therapy designation to patients with a specific type of lung cancer, the pharma maker said it expects regulatory filing in the fourth quarter of this year.
FDA granted the designation to INC280 (capmatinib, Novartis) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC).
“Currently, there are no targeted therapies approved to treat MET exon14 skipping-mutated NSCLC, a particularly aggressive form of the disease,” said Novartis in a statement.
Capmatinib 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.
The MET mutation is seen in an estimated 3% to 4% of all patients with NSCLC. These patients are generally older and often have a poor prognosis that can limit lung cancer treatment options, Novartis said.
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.
Overall response rate among patients receiving capmatinib was 68% for treatment-naive and 41% for previously treated patients. The median duration of response was also clinically meaningful irrespective of prior line of therapy.
“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,” said John Tsai, MD, head of global drug development and chief medical officer at Novartis, in the Novartis statement.
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