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Mirati Therapeutics' Krazati Approved in Europe for KRAS G12C-Mutant NSCLC

NEW YORK – The European Commission on Wednesday granted conditional marketing authorization for Mirati Therapeutics' Krazati (adagrasib) for the treatment of KRAS G12C-mutant advanced non-small cell lung cancer after progression on at least one systemic therapy.

The approval was based on results from 116 NSCLC patients in the Phase II KRYSTAL-1 study. That data showed an overall response rate of 43 percent and an 80 percent disease control rate. Median duration of response on Krazati was 8.5 months.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) initially declined to recommend approval for Krazati. However, after Mirati requested a review of the opinion, CHMP concluded that the data supporting Krazati was sufficient to justify marketing authorization and that the drug had a differentiated safety profile from standard-of-care chemo and Amgen's KRAS inhibitor Lumakras (sotorasib), which was approved in Europe in January 2022.

The US Food and Drug Administration granted approval to Krazati for this same indication in December 2022 alongside two companion diagnostics: Agilent's Resolution ctDx FIRST liquid biopsy test and Qiagen's tissue-based Therascreen KRAS RGQ PCR kit. These tests may be used to identify patients with KRAS G12C mutations who could benefit from treatment with Krazati.