Overview
- The U.S. Food and Drug Administration approved daraxonrasib (Rasonque) for adults with metastatic pancreatic adenocarcinoma who have had prior therapy or cannot receive multiagent chemotherapy, a decision announced on Aug. 26 that follows an expedited review.
- Approval was based on the randomized RASolute 302 Phase 3 trial of about 500 previously treated patients that reported median overall survival of 13.2 months with daraxonrasib versus 6.7 months with chemotherapy and a roughly 60% reduction in risk of death.
- Daraxonrasib works as a small‑molecule 'molecular glue' that binds cyclophilin A to broadly inhibit active RAS proteins, including mutant KRAS that drives over 90% of pancreatic cancers.
- No new safety signals emerged in the trial, but common toxicities such as rash, mouth inflammation, nausea and diarrhea require clinical protocols for management after more than 2,000 patients received the drug through expanded access before approval.
- Immediate priorities include rolling the drug into practice, resolving payer coverage and pricing, and running combination and earlier‑line trials that could expand use and change outcomes for a disease that currently kills most people diagnosed with it.