Mirati’s Krazati Gets Accelerated Approval for NSCLC

The FDA has granted accelerated approval to Mirati Therapeutics’ Krazati (adagrasib) for treatment of adults with KRAS G12C-mutated locally advanced or metastatic nonsmall-cell lung cancer (NSCLC) who have received at least one previous systemic therapy.

The KRASG12C mutation is fairly common, occurring in 13 percent of NSCLC patients.

The accelerated approval decision was based on study results showing an overall response rate of 43 percent and a median duration of response of 8.5 months. Continued approval for Krazati is dependent on verification and description of clinical benefit in one or more confirmatory trials.