FDA’s adagrasib timeline could have major consequences for Mirati

FDA’s decision to conduct a standard review of an NDA for adagrasib puts Mirati at risk of missing its opportunity for accelerated approval in non-small cell lung cancer, a scenario that would add much more than four months to the approval timeline of its lead molecule. 

Mirati Therapeutics Inc. (NASDAQ:MRTX) announced aftermarket Tuesday that FDA had assigned a Dec. 14 PDUFA date to an NDA for adagrasib as second-line therapy for non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation. The company’s shares fell 13% to $93.60 Wednesday, erasing about $700 million of market cap. ...