At least six PDUFA dates on deck for FDA in December

Mirati is eagerly awaiting a Dec. 14 PDUFA date on an application for accelerated approval of its KRAS inhibitor adagrasib for NSCLC. If competing KRAS inhibitor Lumakras from Amgen sees its accelerated approval converted to full approval before then, adagrasib will likely no longer be eligible for accelerated approval, setting back its timeline.

A presentation at ASCO showed KRAS G12C inhibitor adagrasib from Mirati Therapeutics Inc. (NASDAQ:MRTX) led to an objective response rate (ORR) of 43% and a disease control rate of 80% in a Phase II study as second-line therapy to treat non-small cell lung cancer (NSCLC). Lumakras sotorasib from Amgen Inc. (NASDAQ:AMGN) had an ORR of 41% in its Phase I/II study. ...