RASONQUE (daraxonrasib; RMC-6236)
Metastatic pancreatic adenocarcinoma · Adults who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy
RVMD · Revolution Medicines
Regulatory designations
Full timeline
9 milestonesFDA approved RASONQUE for metastatic pancreatic adenocarcinoma
FDA approved once-daily oral RASONQUE for adults with metastatic pancreatic adenocarcinoma who had received at least one prior systemic therapy or were not candidates for multiagent systemic therapy. The indication does not require an identified RAS mutation or a companion diagnostic. FDA completed the review approximately 6.5 months before its goal date.
FDA — Approval of daraxonrasib for metastatic pancreatic adenocarcinoma↗FDA accepted the daraxonrasib NDA for review
FDA accepted the NDA for previously treated metastatic pancreatic ductal adenocarcinoma. The submission was supported by RASolute 302 and was reviewed through the Commissioner’s National Priority Voucher pilot program.
Revolution Medicines — FDA acceptance of the daraxonrasib NDA↗Phase 3 results presented at ASCO and published in NEJM
Detailed RASolute 302 results showed a 60% reduction in the risk of death versus chemotherapy in the overall population. Median overall survival was 13.2 months with daraxonrasib and 6.7 months with chemotherapy; the results were presented in an ASCO plenary session and simultaneously published in The New England Journal of Medicine.
Revolution Medicines — ASCO presentation and NEJM publication of RASolute 302↗Phase 1/2 pancreatic-cancer data published in NEJM
The publication described early clinical efficacy and safety findings from RMC-6236-001 in previously treated metastatic RAS-mutant pancreatic ductal adenocarcinoma, providing clinical support for the Phase 3 program.
Revolution Medicines — NEJM publication of Phase 1/2 daraxonrasib data↗Related News
U.S. FDA Approves Revolution Medicines’ RASONQUE™ (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer
Aug 10, 2026Revolution Medicines and BeOne Medicines Announce Clinical Development and Regional Commercialization Collaboration
Aug 5, 2026Revolution Medicines Reports Second Quarter 2026 Financial Results and Update on Corporate Progress
Jul 29, 2026Revolution Medicines to Report Financial Results for Second Quarter 2026 After Market Close on August 5, 2026
Jul 22, 2026Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic Cancer