Posted by Michael Wonder on 06 Sep 2019
Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA breakthrough therapy designation for patients with MET-mutated advanced non-small cell lung cancer
6 September 2019 - Regulatory filing for capmatinib in the U.S. is anticipated in Q4 2019.
We are pleased to announce that the U.S. 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.
Capmatinib (INC280) is an investigational, oral, highly potent and selective MET inhibitor licensed to Novartis by Incyte Corporation in 2009.
