Mirati announces EMA’s CHMP issued negative opinion on MAA for KRAZATI

Mirati Therapeutics announced the European Medicine Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, issued a negative opinion on the Conditional Marketing Authorisation Application, MAA, for KRAZATI for treatment of patients with KRASG12C -mutated advanced non-small cell lung cancer, NSCLC. Mirati disagrees with the opinion and intends to request a formal re-examination. CHMP states that KRAZATI has a positive risk-benefit profile, however, does not fulfill certain requirements for a Conditional Marketing Authorisation. Mirati believes KRAZATI addresses the Conditional Marketing Authorisation requirements despite there being a currently conditionally approved KRASG12C inhibitor and that KRAZATI possesses a differentiated clinical profile. “We remain steadfast in our belief in the potential of adagrasib to provide hope for patients in the European Union,” said David Meek, chief executive officer, Mirati Therapeutics, Inc. “We will continue to work closely with the EMA and the CHMP to bring adagrasib to eligible patients. We are committed to delivering therapeutic options for patients living with KRASG12C-mutated NSCLC in the EU, as we have in the United States following the Accelerated Approval of KRAZATI in December 2022.” This decision will have no impact on any of Mirati’s clinical trials.