August 26, 2026——The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the treatment of metastatic pancreatic adenocarcinoma, delivering a new option to patients months ahead of schedule.
Rasonque is a once-daily oral tablet that targets multiple forms of the RAS protein, a key driver of tumor growth in most pancreatic cancer patients.
Indication
The approval covers adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
Pancreatic adenocarcinoma accounts for 90-95% of the approximately 67,000 new pancreatic cancer cases diagnosed annually in the U.S. Despite representing only 3.2% of all cancer diagnoses, it accounts for a disproportionately high share of cancer deaths due to late detection, aggressive progression, and limited treatment options.
Clinical Data
In a randomized, open-label, multicenter trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, Rasonque improved median overall survival to 13.2 months compared to 6.7 months for standard chemotherapy.
"This drug showed unprecedented results in an area of high unmet need," said Dr. Angelo de Claro, director of the FDA's Oncology Center of Excellence.
Regulatory Highlights
The approval was granted 6.5 months before the user fee deadline. Rasonque received Breakthrough Therapy and Orphan Drug designations, as well as Priority Review. The application was also reviewed under the Commissioner's National Priority Voucher pilot program, aimed at accelerating reviews for therapies addressing national public health priorities.
In May 2026, the FDA issued a "safe to proceed" letter allowing the sponsor to initiate an expanded access treatment protocol, enabling patient access to the investigational drug before approval.
Safety Profile
The most common side effects include rash, diarrhea, stomatitis (mouth inflammation), nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.
Statement from FDA Leadership
"Today's approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible," said Acting FDA Commissioner Kyle Diamantas.
Sponsor
The FDA granted the approval to Revolution Medicines, Inc.
