Mirati Therapeutics Provides Update on Regulatory Review in the European Union of KRAZATI (adagrasib) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRAS G12C Mutation
Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today 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 ® ( adagrasib ) for treatment of patients with KRAS G12C -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 KRAS G12C inhibitor and that KRAZATI possesses a differentiated clinical profile. Key differentiators include KRAZATI’s efficacy profile, potential central nervous system activity and combinability with other agents,
