Success For Mirati As EMA Backs Krazati For EU Approval After Initial Rejection

Patients with KRASG12C-mutated advanced non-small cell lung cancer (NSCLC) could soon have another treatment option after the European Medicines Agency’s human medicines advisory committee, the CHMP, backed Mirati Therapeutics, Inc.’ Krazati (adagrasib) for conditional approval in the EU.

The good news for Mirati has come four months after an initial disappointing CHMP decision on its conditional marketing authorization (CMA) application for Krazati. In July, the EMA said that Krazati should not be approved on a conditional basis because it believed the medicine did not meet the criteria for granting this type of authorization