Overview
- A randomized Phase 3 trial published May 31 showed daraxonrasib raised median overall survival from about 6.7 months to 13.2 months and cut the risk of death by roughly 60 percent compared with standard chemotherapy.
- The drug works as a 'molecular glue' that binds cyclophilin A to form a complex that disables active mutant KRAS rather than attaching directly to KRAS.
- Common side effects included a widespread rash affecting more than 86 percent of patients plus stomatitis, diarrhea, nausea and vomiting, but patients on daraxonrasib stopped treatment less often and reported better pain and quality‑of‑life measures than those on chemotherapy.
- Because daraxonrasib is not yet approved, the FDA issued a May 1 'safe to proceed' letter for expanded access, and hospitals must join a manufacturer run expanded‑access program that uses a designated specialty pharmacy and per‑patient applications.
- Revolution Medicines is preparing expedited regulatory filings and new trials of combinations and earlier use, and clinicians are monitoring toxicity management, equity of access for community patients, and studies to define biomarkers and resistance mechanisms.