RASONQUE (Daraxonrasib) - (RASolute 302)

August 26, 2026: Revolution Medicines (NASDAQ: RVMD) announced FDA approval of RASONQUE (daraxonrasib) once-daily oral tablets for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The label applies regardless of identified tumor RAS mutation and does not require a companion diagnostic.

Approval was based on the global Phase 3 RASolute 302 trial in previously treated metastatic PDAC. In the intent-to-treat population, RASONQUE reduced risk of death by 60% versus investigator’s choice chemotherapy (OS HR 0.40, 95% CI 0.30–0.53; p<0.0001), with median OS 13.2 months vs 6.7 months. PFS also improved (HR 0.49, 95% CI 0.38–0.64; p<0.0001), with median PFS 7.2 months vs 3.6 months. The trial met all primary and key secondary endpoints in both the RAS G12-mutant and overall ITT populations. Patient-reported outcomes showed delayed deterioration in global health status/quality of life (5.7 vs 2.6 months; HR 0.60; p<0.001) and pain (9.2 vs 3.8 months; HR 0.51; p<0.001).

Common adverse reactions were rash, diarrhea, stomatitis, nausea, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. Results were presented at ASCO 2026 and published in NEJM. The company said RASONQUE is now available in the U.S.; a company webcast is scheduled for August 26, 2026, at 1:30 p.m. ET.