Revolution Medicines Wins FDA Approval for RASONQUE in Metastatic Pancreatic Cancer

Revolution Medicines NASDAQ: RVMD said the U.S. Food and Drug Administration has approved daraxonrasib under the brand name RASONQUE for certain adults with metastatic pancreatic adenocarcinoma. The oral, once-daily RAS(ON) multi-selective inhibitor is approved for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multi-agent systemic therapy. The indication is not limited by tumor RAS mutation status, and no companion diagnostic is required, the company said.

The approval was supported by the global Phase III RASolute 302 study, which compared RASONQUE monotherapy with standard cytotoxic chemotherapy in previously treated metastatic pancreatic cancer. Alan Sandler, Revolution Medicines’ chief development officer, said the study showed a 60% reduction in the risk of death and nearly doubled median overall survival versus chemotherapy. Sandler said RASONQUE also produced a statistically significant improvement in progression-free survival, as assessed by blinded independent central review. In addition, patients receiving RASONQUE experienced a significant delay in deterioration of patient-reported pain and overall quality-of-life measures compared with chemotherapy. The company said it identified no new safety signals in RASolute 302 relative to earlier studies. Treatment-emergent adverse events were generally manageable through established management and dose-modification strategies, while treatment discontinuations due to adverse events were substantially less frequent than with chemotherapy, according to Sandler. Results from RASolute 302 were presented at the 2026 ASCO Congress in May and published simultaneously in the New England Journal of Medicine , Sandler said.

RASONQUE is commercially available in the United States beginning immediately. Anthony Mancini, chief global commercialization officer, said the medicine carries a wholesale acquisition cost of $39,800 for a 30-day supply at the recommended daily dose. The company said its market-access, manufacturing, distribution and patient-support operations are in place for the launch. Its (ON)Path patient-services program will provide coverage navigation, financial support, adherence resources and educational materials for patients, caregivers and healthcare teams. Eligible commercially insured patients may qualify for co-pay assistance as low as $0, Mancini said. He added that commercially insured patients already receiving daraxonrasib through the company’s expanded access program are expected to transition to commercial supply within a few months.