FDA accepts New Drug Application for daraxonrasib in previously treated metastatic pancreatic cancer

Revolution Medicines announced that the FDA accepted the daraxonrasib NDA under Real-Time Oncology Review; with a National Priority Voucher, the review period is expected to be dramatically shortened.

In July 2026 Revolution Medicines announced that the U.S. FDA had accepted for review its New Drug Application (NDA) for daraxonrasib in previously treated patients with metastatic pancreatic cancer.

The application is based on the positive results of the Phase 3 RASolute 302 trial. Because daraxonrasib received a Commissioner's National Priority Voucher (CNPV) in October 2025 and was included in the Real-Time Oncology Review (RTOR) pilot, the review was expected to take only 1–2 months. The FDA ultimately approved the drug on August 26, 2026.