Washington, D.C. — August 27, 2026 — The United States Food and Drug Administration granted expedited approval on Wednesday, August 26, 2026, to daraxonrasib, a first-of-its-kind oral medication designed to treat advanced metastatic pancreatic cancer. Marketed under the brand name Rasonque by Redwood City, California-based drugmaker Revolution Medicines, the once-daily pill targets mutated proteins that drive tumor growth across the vast majority of pancreatic ductal adenocarcinoma cases.
Federal regulators approved the therapy approximately six and a half months ahead of the scheduled user fee deadline. Acting FDA Commissioner Kyle Diamantas emphasized that the accelerated clearance underscores the agency's commitment to expediting treatments for severe and life-threatening conditions. The drug is indicated for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who cannot tolerate multiagent chemotherapy regimens.
Clinical Trial Results and Survival Metrics
The approval is backed by data from the Phase 3 RASolute 302 clinical trial, which evaluated 500 adult patients with previously treated metastatic disease. Participants randomized to receive the 300 mg daily dose of daraxonrasib achieved a median overall survival of 13.2 months, compared to 6.7 months for patients receiving investigator-choice standard chemotherapy regimens.
Furthermore, the trial demonstrated a median progression-free survival of 7.2 months for patients taking the targeted pill, against 3.6 months for the control arm. Medical experts noted that while the treatment is not a cure, it effectively doubles survival duration in a cancer category where treatment breakthroughs have remained rare for decades.
Mechanism of Action and Overcoming the Undruggable RAS Protein
For more than forty years, scientists categorized the RAS gene family as undruggable because its structural configuration prevented conventional medicines from attaching effectively to the mutated proteins. Mutations in these genes drive tumor proliferation in over 90 percent of pancreatic cancer cases.
Daraxonrasib overcomes this biological barrier by utilizing a molecular mechanism that binds to cellular cyclophilin A proteins to form a complex capable of clamping onto multiple active RAS subtypes, including G12D, G12V, and G12R. Common side effects reported during clinical evaluations include skin rashes, diarrhea, stomatitis, fatigue, and nausea.
Pricing, Commercial Rollout, and Access
Revolution Medicines announced that Rasonque will carry a list price of approximately $39,800 for a one-month supply, translating to an annual cost exceeding $475,000. Prior to formal approval, high public interest prompted the FDA to authorize an expanded access program following public disclosures by prominent patients, including former U.S. Senator Ben Sasse.
Commercial shipments and hospital distribution channels are scheduled to begin nationwide deliveries starting September 8, 2026.
What caused the FDA to grant expedited approval for daraxonrasib?
The FDA granted expedited approval for daraxonrasib because Phase 3 clinical trial results demonstrated an unprecedented doubling of median overall survival rates in patients with advanced, treatment-resistant pancreatic cancer.
Commercial shipments and hospital distribution channels are scheduled to begin nationwide deliveries starting September 8, 2026.