Mirati Therapeutics (NASDAQ: MRTX) shares surged Tuesday after the drugmaker’s new lung cancer treatment adagrasib received Food and Drug Administration (FDA) approval.
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).
Said CEO David Meek, "The FDA approval of KRAZATI is a positive development for thousands of patients with KRAS mutations, including the approximately 14% of patients with NSCLC adenocarcinomas histology that harbor a KRAS 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.
"We look forward to continuing to advance our KRAZATI development program including several monotherapy and combination studies in KRAS mutated solid tumors."
KRAZATI has demonstrated a positive benefit-risk profile with accelerated approval based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating KRAZATI 600 mg capsules administered orally twice daily in 116 patients with KRAS-mutated advanced NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor. The primary efficacy endpoints were confirmed ORR and DOR as evaluated by blinded independent central review according to response evaluation criteria in solid tumors.
MRTX shares declined $2.65, or 6.4%, to $38.76.
