Mirati Therapeutics (MRTX) Provides Update on Regulatory Review in EU of KRAZATI

July 21, 2023 7:58 AM EDT

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 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. Key differentiators include KRAZATI's efficacy profile, potential central nervous system activity and combinability with other agents, including concurrent with or following treatment with an immune checkpoint inhibitor.

"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."

The MAA for KRAZATI was based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating KRAZATI 600 mg administered orally twice daily in 116 patients with KRASG12C-mutated advanced NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor.

Mirati is supplying KRAZATI to eligible European patients with a KRASG12C mutation based on individual requests from healthcare professionals. Mirati intends to continue supplying KRAZATI under early access in EU Member States in alignment with applicable laws and regulations.

This decision will have no impact on any of Mirati's clinical trials. Study enrollment for KRYSTAL-12, the confirmatory Phase 3 trial evaluating adagrasib versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRASG12C mutation, is progressing as expected. Progression-free survival and interim overall survival results are anticipated in the first half of 2024.

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