Mirati Therapeutics receives conditional authorization for KRAZATI from EC

Mirati Therapeutics announced that the European Commission, or EC, granted conditional marketing authorization for KRAZATI, or adagrasib, as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer, or NSCLC, and disease progression after at least one prior systemic therapy. KRAZATI has demonstrated a positive benefit-risk profile 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. The primary efficacy endpoints were confirmed ORR and DOR as evaluated by blinded independent central review according to response evaluation criteria in solid tumors. Conditional marketing authorization for KRAZATI is valid in all 27 EU member states plus Iceland, Norway and Liechtenstein. This authorization follows the positive opinion adopted by the Committee for Medicinal Products for Human Use in November 2023.