Another Competitor For Amgen As FDA Approves Mirati Therapeutics' KRAS Inhibitor For Lung Cancer Setting

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  • The FDA granted accelerated approval to Mirati Therapeutics Inc MRTX Krazati (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
  • The approval covers patients who have received at least one prior systemic therapy.
  • Related: Mirati Experimental Lung Cancer Drug Shows Favorable Tolerability, Promising Efficacy.
  • 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 verifying and describing a clinical benefit in a confirmatory trial(s).
  • The trial demonstrated an ORR of 43%, with 80% of patients achieving disease control. The median DOR was 8.5 months.
  • In a pooled efficacy analysis (n=132) including Phase 1/1b NSCLC and registrational Phase 2 NSCLC cohorts, adagrasib showed an ORR of 44% and a disease control rate of 81%, a median DOR of 12.5 months and median overall survival of 14.1 months.
  • Last month, Mirati was reportedly amid fresh takeover interest from large pharmaceutical companies.
  • Price Action: MRTX shares are up 14.95% at $47.60 during the premarket session on the last check Tuesday.
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