The approval is based on the Phase 3 RASolute 302 trial, published in the New England Journal of Medicine. Against chemotherapy, RASONQUE cut the risk of death by 60 percent, with median overall survival of 13.2 months versus 6.7 months. No companion diagnostic is required.

The drug remains investigational outside the US; the EMA has begun a phased review, a pathway toward eventual European and Nordic availability.

CEO Mark A. Goldsmith called RAS “one of the most intractable disease targets since its discovery decades ago.”