Daraxonrasib (RMC-6236) - (RASolute 302)

July 22, 2026: Revolution Medicines, Inc. (NASDAQ: RVMD) announced the FDA accepted for review its New Drug Application for daraxonrasib (RMC-6236), an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

The NDA is supported by the global, randomized Phase 3 RASolute 302 trial (NCT06625320), which compared daraxonrasib 300 mg once daily vs investigator’s choice of four standard cytotoxic chemotherapy regimens in previously treated metastatic PDAC patients, including those with RAS G12 mutations and those without an identified tumor RAS mutation. The trial met all primary and key secondary endpoints, including improvements in overall survival and progression-free survival, and showed a manageable safety profile. Patient-reported outcomes favored daraxonrasib, with delayed deterioration in cancer-related pain, global health status, and quality of life vs chemotherapy. Data were presented at the 2026 ASCO Annual Meeting with simultaneous publication in The New England Journal of Medicine.

Daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program and previously received FDA Breakthrough Therapy and Orphan Drug designations in this setting. The company also noted EMA CHMP has begun a phased review; daraxonrasib has EMA orphan designation and Cancer Medicines Pathfinder high-priority status.