U.S. FDA announces Accelerated Approval of KRAZATI™ (adagrasib) for Patients with Locally Advanced or Metastatic NSCLC with a KRASG12C Mutation

“The FDA approval of KRAZATI is a positive development for thousands of patients with KRASG12C mutations, including the approximately 14% of patients with NSCLC adenocarcinomas histology that harbor a KRASG12C mutation. Mirati is thrilled to make KRAZATI available in a tablet formulation to patients in the U.S. with advanced NSCLC who have progressed beyond a first-line treatment for the historically difficult-to-treat KRAS mutation,” David Meek, chief executive officer, Mirati Therapeutics, Inc., continued, “We look forward to continuing to advance our KRAZATI development program including several monotherapy and combination studies in KRASG12C-mutated solid tumors.”