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The European Commission has granted conditional marketing authorization to adagrasib for use in adult patients with advanced non–small cell lung cancer harboring a KRAS G12C mutation whose disease progressed following at least 1 prior systemic treatment.
After a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on the conditional marketing authorization application for adagrasib in the treatment of adult patients with KRAS G12C–mutated advanced non–small cell lung cancer whose disease progressed following at least 1 prior systemic treatment.
The phase 2 KRYSTAL-7 trial evaluated adagrasib plus pembrolizumab in patients with KRAS-mutated non–small cell lung cancer (NSCLC) with high PD-L1 expression. The results demonstrated “encouraging preliminary activity.”
Adagrasib monotherapy provided durable efficacy for patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer, according to 2-year follow-up data from the phase 1/2 KRYSTAL-1 trial.
The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the conditional marketing authorization application for adagrasib for the treatment of patients with KRAS G12C–mutated advanced non–small cell lung cancer.