'Breakthrough' designation for Novartis' capmatinib

The US Food and Drug Administration has 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 Dr John Tsai, head of global drug development and chief medical officer of Novartis (NOVN: VX), which gained rights to the compound from Incyte Corp (Nasdaq: INCY).

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.

“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.