Mirati Therapeutics rises as it begins NDA submission for adagrasib

Shares of US oncology focussed biotech Mirati Therapeutics (Nasdaq: MRTX) were up 9.1% at $174.50 pre-market today, after it announced that the US Food and Drug Administration will review the company's New Drug Application (NDA) for adagrasib for the treatment of patients with previously treated KRASG12C-mutated non-small cell lung cancer (NSCLC) who have received prior systemic therapy under the Real-Time Oncology Review (RTOR) pilot program.

The RTOR status follows the previously announced FDA Breakthrough Therapy designation for adagrasib in the same indication. The company says it expects to complete the adagrasib NDA submission to the FDA by the end of 2021.

Preliminary results from the Phase Ib cohort of the KRYSTAL-1 study evaluating adagrasib plus pembrolizumab in eight patients with KRASG12C-mutated first-line NSCLC support moving forward with a 400mg BID dose of adagrasib with full dose pembrolizumab, which will be evaluated in the ongoing Phase II KRYSTAL-7 study.