Mirati Therapeutics (NASDAQ: MRTX) has been granted accelerated approval from the U.S. Food and Drug Administration (FDA) for KRAZATI™ (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

The approval was granted under the FDA's Accelerated Approval (Subpart H) program, which allows for the approval of drugs that treat serious conditions and fill an unmet medical need based on surrogate endpoints.

KRAZATI was evaluated in the KRYSTAL-1 study, which looked at its effectiveness in treating KRASG12C-mutated advanced NSCLC in patients who had previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor.

The company says that the trial study showed that KRAZATI had an objective response rate of 43% and a disease control rate of 80%, with a median duration of response of 8.5 months.

In a pooled efficacy analysis that included both Phase 1/1b and registrational Phase 2 NSCLC cohorts, KRAZATI showed an overall response rate of 44%, a disease control rate of 81%, and a median duration of response of 12.5 months.

The safety profile of KRAZATI was also evaluated, with the most common adverse reactions being nausea, diarrhea, vomiting, and fatigue. Permanent discontinuation of KRAZATI due to adverse reactions occurred in 13% of patients.

The company says that KRAZATI was also reviewed under the FDA's Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible.

Mirati Therapeutics has partnered with Agilent and QIAGEN to develop blood- and tissue-based companion diagnostics (CDx) for KRAZATI, which are now available.

These CDx solutions help to personalize a patient's treatment path by providing greater flexibility and options for biomarker testing. The availability of tissue and blood modalities for companion diagnostics allows clinicians to better tailor treatment to individual patients.

Shares of Mirati Therapeutics trade on the NASDAQ under the ticker symbol MRTX. For more information visit www.mirati.com.