FDA approves daraxonrasib, a first-in-class RAS inhibitor, in previously treated metastatic pancreatic cancer

On 26 August 2026 the FDA approved daraxonrasib (Rasonque), a first-in-class inhibitor of RAS proteins, for adults with metastatic pancreatic ductal adenocarcinoma after at least one prior systemic therapy or who are not candidates for multiagent chemotherapy. In the randomised phase 3 RASolute 302 trial (500 patients, compared with physician's choice chemotherapy) median overall survival was 13.2 versus 6.7 months in the overall population (HR 0.40), and 13.2 versus 6.6 months in the RAS G12-mutated population (HR 0.40; 95% CI 0.30-0.54). Median progression-free survival improved from 3.5 to 7.3 months (HR 0.45) and the objective response rate rose from 11% to 30%. Median follow-up was 8.5 months, so long-term survival data remain immature.