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Mirati’s Krazati Gets Accelerated Approval for NSCLC

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.

About Mirati Therapeutics

Mirati Therapeutics is an American targeted oncology company that focuses on the development of cancer therapeutics. Mirati Therapeutics works largely in KRAS-mutation inhibition, and developing treatments for tumors that contain it. The inhibition to the mutation has shown to shrink the size of its tumors. The company is based in San Diego, California. The company’s name comes from the Italian word for “targeted” (Mirati). Mirati Therapeutics is traded on the NASDAQ under the ticker symbol MRTX. It joined the exchange in 2013. The company’s leading drug candidates are sitravatinib and adagrasib. Mirati also has a preclinical candidate against the G12D mutation.The company’s CEO and President is David Meek.

December 14, 2022


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