Overview
- The FDA granted approval on Aug. 26 for daraxonrasib (Rasonque) for adults with metastatic pancreatic ductal adenocarcinoma after at least one prior systemic therapy or for patients who cannot tolerate multiagent chemotherapy.
- Approval was based on the randomized phase 3 RASolute 302 trial of about 500 patients in which median overall survival was 13.2 months on daraxonrasib versus 6.7 months on investigator‑choice chemotherapy.
- Daraxonrasib works by a ‘molecular glue’ mechanism that first binds cyclophilin A to create a tricomplex that clamps onto active RAS, allowing the pill to inhibit multiple KRAS subtypes long considered undruggable.
- The trial showed fewer grade 3 or higher treatment‑related adverse events overall versus chemotherapy but notable toxicities include rash, stomatitis and gastrointestinal effects that will require clinical monitoring and dose management.
- Revolution Medicines supplied the drug to more than 2,000 patients under expanded access before approval and commercial questions remain about rollout, insurer coverage and conflicting early reports on pricing.