Revolution Medicines receives FDA approval for Rasonque (daraxonrasib) under the Commissioner’s National Priority Voucher pilot program
Revolution Medicines' Rasonque (daraxonrasib) was approved by the FDA on August 26, 2026 for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. This approval comes just over a month after the FDA had accepted the filing for review.
In June 2025, FDA Commissioner Marty Makary launched the Commissioner's National Priority Voucher (CNPV) pilot program, that aimed to shorten the FDA review of drugs from a typical 10–12 months to 1–2 months. Revolution Medicines was one of nine companies named in the first batch of recipients.
Daraxonrasib (RMC-6236) is an oral RAS inhibitor for metastatic pancreatic cancer, which has historically had very poor five-year survival rates. In a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, Rasonque improved median overall survival to 13.2 months compared to 6.7 months for standard chemotherapy. Given this promising efficacy the FDA had permitted Revolution Medicines to initiate an expanded access treatment protocol for daraxonrasib to grant patients access prior to formal FDA approval.
