The Food and Drug Administration granted a priority review to Krazati plus Erbitux for KRAS G12C-mutant locally advanced or metastatic colorectal cancer.
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 dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
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.