On August 26, 2026, the U.S. Food and Drug Administration approved Rasonque (daraxonrasib), a first-in-class oral RAS inhibitor, for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. The approval was granted to Revolution Medicines, Inc.
Rasonque is formulated as a tablet taken once daily and is intended to provide an additional therapeutic option for a disease that is typically detected late and has limited historically effective treatments.
Rasonque (daraxonrasib) is described as a targeted inhibitor that acts against multiple forms of the RAS protein. RAS proteins are key drivers of tumor growth in most cases of pancreatic adenocarcinoma, which arises from the ductal cells of the pancreas. By targeting RAS, the drug is designed to interfere directly with a central oncogenic pathway implicated in the majority of pancreatic adenocarcinomas.
The approval was supported by data from a randomized, open-label, multicenter trial that enrolled 500 adults with previously treated metastatic pancreatic adenocarcinoma. In that study, treatment with Rasonque improved median overall survival to 13.2 months compared with 6.7 months for patients who received standard chemotherapy. The trial population consisted of adults who had received prior systemic therapy; the press release does not report further details such as stratification, secondary endpoints, or subgroup analyses.
These survival results were highlighted by FDA officials as unprecedented in an area of high unmet need and formed the principal efficacy basis cited in the approval announcement.
Rasonque received several expedited and supportive regulatory designations from the FDA: Breakthrough Therapy and Orphan Drug designations, and Priority Review for the indication at approval. The application was also reviewed under the Commissioner’s National Priority Voucher (CNPV) pilot program, which aims to accelerate review of therapies that address national public health priorities.
In May 2026, prior to approval, the FDA issued a “safe to proceed” letter that permitted the sponsor to implement an expanded access treatment protocol, enabling access to the investigational drug under applicable FDA regulations before formal approval.
FDA statements noted that the approval was issued 6.5 months before the user fee deadline, illustrating the agency’s intent to move with urgency on important new cancer therapies.
The press release lists the most commonly observed side effects associated with Rasonque. These include rash, diarrhea, stomatitis (inflammation of the mouth’s mucous membranes), nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. The announcement does not provide incidence rates, severity grading, or recommended management strategies for these adverse events; such details were not reported in the source.
The FDA granted approval to Revolution Medicines, Inc. The agency described the approval as delivering a new treatment option months ahead of schedule and emphasized the role of FDA scientists in conducting a rapid, thorough review.
The release framed Rasonque’s approval within the broader public health challenge posed by pancreatic adenocarcinoma. The National Cancer Institute estimates reported in the release indicate roughly 67,000 new cases of pancreatic cancer are diagnosed annually in the United States; approximately 90% to 95% of these are pancreatic adenocarcinoma. Although pancreatic adenocarcinoma represents about 3.2% of cancer diagnoses, it accounts for a disproportionately high share of cancer deaths because of late presentation, aggressive disease behavior, and limited prior options.
Acting FDA Commissioner Kyle Diamantas, J.D., is quoted in the announcement underscoring the agency’s duty to expedite meaningful treatments and applauding the FDA team’s expedited review. Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence, described the trial results as unprecedented for this high unmet need and noted the early approval relative to the user fee deadline.
The press release positions the approval as part of the FDA’s efforts to reduce unnecessary delays and advance innovative therapies that can meaningfully affect patients and families facing serious illnesses.
The release includes media and consumer contact points: the FDA Request for Comment link and phone contacts for media and consumer inquiries. It also reiterates the FDA’s public health mission and lists that the content was current as of 08/26/2026. The announcement does not include detailed prescribing information, dosing adjustments, contraindications, or monitoring recommendations; those specifics were not reported in the source.