AMGN - Mirati KRAS inhibitor goes under FDA review for lung cancer

Mirati Therapeutics (NASDAQ:MRTX) is trading ~7% lower in the pre-market on Wednesday after the company announced that the U.S. Food and Drug Administration (FDA) accepted its marketing application for KRASG12C inhibitor adagrasib for accelerated approval. The New Drug Application (NDA) for oral therapy was accepted by the federal agency as a potential treatment for patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation as a second-line option, Mirati (MRTX) said in a statement on Tuesday. With the drug being reviewed under Accelerated Approval (Subpart H), the regulator is expected to make its decision by Dec. 14, 2022, the company added. "The acceptance of our NDA for adagrasib is a significant step forward in Mirati's ongoing efforts to advance innovative, differentiated treatment options for patients with KRASG12C cancers," Head of R&D of Mirati (MRTX) Charles Baum remarked. Last May, Amgen (NASDAQ:AMGN) shares spiked after the FDA greenlighted Lumakras (sotorasib) for adults

For further details see:

Mirati KRAS inhibitor goes under FDA review for lung cancer