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

by Vandana Singh, Benzinga Editor
December 13, 2022 6:45 AM | 1 min read |
  • 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.
Market News and Data brought to you by Benzinga APIs

© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Comments
Posted In: BiotechNewsHealth CareFDAMoversTrading IdeasGeneralBriefspremarket tradingwhy it's moving
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!