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Overview
- The FDA approved daraxonrasib, branded Rasonque, for adults with metastatic pancreatic adenocarcinoma who have had prior systemic therapy or cannot receive combination chemotherapy.
- A randomized Phase 3 trial of 500 patients showed median overall survival of 13.2 months with daraxonrasib versus 6.7 months with standard chemotherapy, a result that underpinned the approval.
- Daraxonrasib works through a molecular‑glue mechanism that first binds cyclophilin A to create a new surface that clamps onto multiple active forms of RAS, allowing the drug to block KRAS mutations that drive most pancreatic cancers.
- Regulators allowed expanded access beginning in May and Revolution Medicines supplied the drug to more than 2,000 patients before formal clearance, while the FDA fast‑tracked review with Breakthrough and Priority designations.
- Clinicians must manage common toxicities such as severe rash and stomatitis, payers and the company must resolve pricing and coverage for broad access, and ongoing trials will test combinations and first‑line use to extend benefit.