# RASONQUE (daraxonrasib; RMC-6236) PDUFA Event: Metastatic pancreatic adenocarcinoma Canonical URL: https://biopharmsignal.com/pdufa-calendar/RVMD/daraxonrasib-metastatic-pancreatic-adenocarcinoma Ticker: RVMD Company: Revolution Medicines Event date: 2026-08-26 Event type: FDA Decision Stage: PDUFA Result: Approved Result date: 2026-08-26 Application type: NDA FDA approved RASONQUE for metastatic pancreatic adenocarcinoma. FDA approved once-daily oral RASONQUE for adults with metastatic pancreatic adenocarcinoma wh... ## Event Timeline ### August 26, 2026 — FDA 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](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma) ### July 22, 2026 — 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](https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-new-drug-application-daraxonrasib-accepted/) ### May 31, 2026 — 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](https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-announces-asco-plenary-presentation/) ### May 6, 2026 — 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](https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-announces-publication-new-england-journal/) ### May 1, 2026 — FDA permitted a daraxonrasib expanded-access protocol FDA issued a safe-to-proceed letter allowing Revolution Medicines to initiate an expanded-access treatment protocol for patients with previously treated metastatic pancreatic ductal adenocarcinoma. [FDA — Expanded access permitted for investigational daraxonrasib](https://www.fda.gov/news-events/press-announcements/fda-permits-expanded-access-investigational-pancreatic-cancer-drug) ### April 13, 2026 — RASolute 302 reported positive topline results The randomized Phase 3 trial met all primary and key secondary endpoints. Daraxonrasib significantly improved overall survival and progression-free survival versus standard chemotherapy, with no new safety signals reported. [Revolution Medicines — Positive topline Phase 3 RASolute 302 results](https://ir.revmed.com/news-releases/news-release-details/daraxonrasib-demonstrates-unprecedented-overall-survival-benefit/) ### October 21, 2025 — FDA granted Orphan Drug designation FDA designated daraxonrasib as an orphan drug for the treatment of pancreatic cancer. [FDA — Orphan Drug designation record for daraxonrasib](https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1098125) ### June 23, 2025 — FDA granted Breakthrough Therapy designation FDA granted Breakthrough Therapy designation for previously treated metastatic pancreatic ductal adenocarcinoma with KRAS G12 mutations based on early clinical evidence from RMC-6236-001. [Revolution Medicines — FDA Breakthrough Therapy designation](https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-announces-fda-breakthrough-therapy) ### October 21, 2024 — First patient dosed in Phase 3 RASolute 302 Revolution Medicines reported the first patient dosed in the registrational trial comparing daraxonrasib with investigator-selected standard chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma. [Revolution Medicines — RASolute 302 first-patient dosing update](https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-reports-third-quarter-2024-financial/) ## Regulatory Designations - Breakthrough Therapy FDA: [Revolution Medicines — FDA Breakthrough Therapy designation](https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-announces-fda-breakthrough-therapy) - Orphan Drug FDA: [FDA — Orphan Drug designation record for daraxonrasib](https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1098125) ## Related Pages - RVMD PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/RVMD.md - RVMD company profile: https://biopharmsignal.com/company/RVMD.md - PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md ## Related News - 2026-09-02 — New England Journal of Medicine Publishes Phase 1/2 Clinical Data on Revolution Medicines’ RASONQUE™ (daraxonrasib) in Metastatic Non-Small Cell Lung Cancer: https://biopharmsignal.com/news/RVMD/new-england-journal-of-medicine-publishes-phase-1-2-clinical-data-on-revolution--6b8b2e92.md - 2026-08-26 — U.S. FDA Approves Revolution Medicines’ RASONQUE™ (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer: https://biopharmsignal.com/news/RVMD/u-s-fda-approves-revolution-medicines-rasonque-daraxonrasib-the-first-broad-ras--075ffdd6.md - 2026-08-10 — Revolution Medicines and BeOne Medicines Announce Clinical Development and Regional Commercialization Collaboration: https://biopharmsignal.com/news/RVMD/revolution-medicines-and-beone-medicines-announce-clinical-development-and-regio-a4f15a3d.md - 2026-08-05 — Revolution Medicines Reports Second Quarter 2026 Financial Results and Update on Corporate Progress: https://biopharmsignal.com/news/RVMD/revolution-medicines-reports-second-quarter-2026-financial-results-and-update-on-fd8742ee.md - 2026-07-29 — Revolution Medicines to Report Financial Results for Second Quarter 2026 After Market Close on August 5, 2026: https://biopharmsignal.com/news/RVMD/revolution-medicines-to-report-financial-results-for-second-quarter-2026-after-m-4ad84d96.md