Overview
- The Phase 3 trial presented May 31 showed daraxonrasib extended median overall survival from about 6.7 months to roughly 13.2 months and cut the risk of death by about 60% compared with standard chemotherapy.
- Daraxonrasib is a once‑daily oral drug that works by binding cyclophilin A to disable active mutant KRAS, a driver in more than 90% of pancreatic tumors.
- Common side effects include a prominent rash in most patients plus mouth sores, diarrhea, nausea and vomiting yet patients stopped treatment less often than those on chemotherapy and reported lower pain.
- The FDA issued a 'safe to proceed' expanded access pathway and signaled expedited review while Revolution Medicines prepares formal approval filings, creating strong patient demand before full authorization.
- Hospitals and specialty pharmacies face operational strain because the expanded access program requires case‑by‑case institutional applications and a manufacturer‑designated distributor, raising concerns about supply, equity and next‑step trials in earlier disease and combinations.