The U.S. Food and Drug Administration (FDA) has approved Rasonque (daraxonrasib), a RAS inhibitor designed for the most common form of pancreatic cancer. The decision introduces a new treatment option for patients with advanced pancreatic cancer and comes months ahead of schedule. The agency said the action reflects its commitment to acting with urgency, limiting unnecessary delays and supporting the development of innovative treatments that can make a meaningful difference for American patients and their families. The FDA granted the approval to Revolution Medicines, Inc.
Rasonque is administered as a tablet once daily and works by targeting multiple forms of a protein called RAS. The protein is a key driver of tumor growth in most patients with pancreatic adenocarcinoma, a cancer that develops from cells lining the ducts of the pancreas. The approval covers adults with metastatic pancreatic cancer in the form of pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
“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, J.D.
“I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality,” he added.
Clinical Trial Shows Survival Benefit
Pancreatic adenocarcinoma represents approximately 90% to 95% of the 67,000 new cases of pancreatic cancer diagnosed in the United States each year, according to the National Cancer Institute. Although pancreatic adenocarcinoma makes up roughly 3.2% of all cancer diagnoses, it contributes a disproportionately high share of cancer deaths. The source attributes that burden to the disease’s typically late detection, aggressive course and historically limited treatment options.
Evidence supporting Rasonque came from a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma. In the study, Rasonque increased median overall survival to 13.2 months, compared with 6.7 months for standard chemotherapy.
“This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence.
“The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA’s commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions,” he added.
Rasonque Receives Multiple FDA Designations
The FDA granted Rasonque Breakthrough Therapy and Orphan Drug designations, while the treatment also received Priority Review for this indication. The application underwent an additional review through the Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the review of therapies addressing national public health priorities.
In May 2026, the FDA issued a “safe to proceed” letter allowing the sponsor to begin an expanded access treatment protocol for Rasonque. This enabled patient access to the investigational drug before approval under applicable FDA regulations.
