Mirati Therapeutics: CHMP Issues Negative Opinion On Conditional MAA For KRAZATI

(RTTNews) - Mirati Therapeutics, Inc. (MRTX) announced the European Medicine Agency's Committee for Medicinal Products for Human Use issued a negative opinion on the Conditional Marketing Authorisation Application for KRAZATI for treatment of patients with KRASG12C -mutated advanced non-small cell lung cancer. The company plans to request a formal re-examination.

David Meek, CEO, said: "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."

Shares of Mirati Therapeutics are down 5% in pre-market trade on Friday.

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