EC approves Krazati for NSCLC
The European Commission (EC) has granted conditional marketing authorization for Krazati (adagrasib), from US biotech Mirati Therapeutics (Nasdaq: MRTX), as a targeted treatment option for adult patients with KRASG12C-mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy.
Krazati has demonstrated a positive benefit-risk profile based on the Phase II registration-enabling cohort of the KRYSTAL-1 study, evaluating Krazati 600mg 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 (BICR) according to response evaluation criteria in solid tumors (RECIST v1.1).
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