Shots:

• The US FDA has accepted NDA and granted PR designation to Capmatinib as a 1L treatment for LA/m- MET exon 14 skipping (METex14) mutated NSCLC
• The NDA submission is based on GEOMETRY mono-1 P-II study that demonstrated ORR (67.9%) assessed by BIRC assessment per RECIST v1.1- mDOR (11.4 and 9.72 mos.) in treatment naïve and prior treated patients respectively
• Capmatinib (INC280) is an investigational- oral- potent and selective MET inhibitor with its expected review to be completed within 6mos. The therapy is licensed from Incyte in 2009- under which Novartis got WW exclusive development and commercialization rights for the therapy and certain back-up compounds in all indications

Click here to­ read full press release/ article | Ref: Novartis | Image: WSJ