Mirati To Challenge EMA’s Rejection Of US-Approved Krazati

Drug Was Granted Accelerated Approval By US FDA In December 2022

Mirati Therapeutics said it disagreed with the European Medicines Agency’s decision that its lung cancer drug did not meet its conditional marketing authorization criteria.

Concept of EMA European Medicines Agency. Drugs evaluation and quality control. — The EMA says Krazati should not be approved in the EU • Source: Shutterstock

Mirati Therapeutics is to appeal against the European Medicines Agency’s recommendation that pan-EU marketing approval should be refused for Krazati (adagrasib), the company’s US-approved treatment for KRASG12C -mutated advanced non-small cell lung cancer (NSCLC).

Mirati was seeking a conditional marketing authorization for the drug, but the EMA said today that the medicine did not...