Revolution Medicines won FDA approval for RASONQUE (daraxonrasib) on August 26, 2026, marking the first targeted medicine designed to directly inhibit RAS, the primary driver of pancreatic cancer and one of the most difficult protein targets in oncology to address.
The once-daily oral drug is indicated for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for chemotherapy. The approval was based on the Phase 3 RASolute 302 trial, which showed RASONQUE reduced the risk of death by 60% compared with standard chemotherapy, with a hazard ratio of 0.40 (95% CI: 0.30–0.53; p<0.0001).
In the trial, the median overall survival with RASONQUE was 13.2 months, compared to 6.7 months with chemotherapy—nearly doubling survival time. Progression-free survival also improved significantly, with a median of 7.2 months versus 3.6 months with chemotherapy. The drug does not require a companion diagnostic test, meaning patients with or without an identified RAS mutation can receive treatment.
Pancreatic cancer remains one of the deadliest malignancies. Approximately 55,000 people are diagnosed with metastatic pancreatic adenocarcinoma in the U.S. each year, and the five-year relative survival rate for distant-stage disease is approximately 3%, according to Revolution Medicines’ disclosure. Most patients with metastatic disease have a median survival of 3 to 6 months under current standard of care, making any significant extension of survival a major clinical advance.
The FDA granted RASONQUE accelerated approval through its Commissioner’s National Priority Voucher program, which is designed to expedite review of medicines addressing key national health priorities. The approval came more than six months ahead of the FDA’s standard timeline, according to reporting on the drug’s development. The drug was also selected for the FDA’s Project Orbis initiative, allowing concurrent review by international regulatory authorities.
Revolution Medicines priced RASONQUE at $39,800 for a 30-day supply at the recommended daily dose of 300 mg. The company launched a patient support program called (ON) Path to help eligible patients navigate insurance coverage and access the medication.
Wall Street analysts have responded positively to the approval. According to recent analyst consensus, 22 analysts covering Revolution Medicines rate the stock as “Strong Buy,” with an average 12-month price target of $223.24, representing potential upside from the stock’s recent trading levels around $213. However, shares traded relatively flat on the approval day itself, with market observers attributing the muted reaction to concerns about the drug’s high price tag and questions about real-world uptake.
The approval represents a milestone in RAS-targeted drug development, a field that was once considered intractable. For decades, RAS mutations were viewed as “undruggable” due to the protein’s structure and function. While other RAS inhibitors have been approved for specific mutations in lung cancer, RASONQUE is the first broad RAS-targeted medicine that works across multiple RAS genotypes and does not require genetic testing to determine eligibility, expanding potential patient access.
Brian M. Wolpin, M.D., director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute and principal investigator for the RASolute 302 trial, stated in the company’s press release that “this approval gives physicians the confidence that directly inhibiting RAS can make a striking difference for patients and provides a critically needed new approach to treating patients with metastatic pancreatic cancer.”
Sources
- Revolution Medicines Investor Relations — FDA approval announcement, trial data, and pricing for RASONQUE (daraxonrasib)
- STAT News — Trial survival data and approval details for the pancreatic cancer drug
- Washington Post — Clinical trial results showing nearly doubled survival times
- Stock Analysis — Analyst ratings and 12-month price target consensus for RVMD
- Newsweek — RASONQUE pricing and cost information
- Pancreatic Cancer Action Network (PanCAN) — Context on pancreatic cancer epidemiology and clinical significance
