FDA Clears Expanded Access to Promising Pancreatic Cancer Drug Daraxonrasib

The Food and Drug Administration cleared an expanded access path for daraxonrasib, a move that could bring Revolution Medicines’ experimental pancreatic cancer drug to some patients with previously treated metastatic pancreatic ductal adenocarcinoma while regulators continue reviewing its broader future.

The agency said May 1 that it issued a “safe to proceed” letter after receiving Revolution Medicines’ request on April 28 and signing off on April 30. The protocol applies to patients with previously treated metastatic PDAC, the aggressive disease that has long had few effective options and remains one of the deadliest cancers.

The regulatory step follows late-stage data that helped persuade the agency to move quickly. On April 13, Revolution Medicines said its global Phase 3 RASolute 302 trial met its primary and key secondary endpoints. Daraxonrasib, also known as RMC-6236, produced a median overall survival of 13.2 months compared with 6.7 months for standard chemotherapy, with a hazard ratio of 0.40 and p<0.0001 for overall survival. The company said the drug was generally well tolerated and reported no new safety signals.

The FDA said daraxonrasib is designed to inhibit RAS, a protein mutated in most pancreatic cancer tumors. The agency also noted that the drug had already received Breakthrough Therapy, Orphan Drug and national priority voucher designations. Revolution Medicines, based in Redwood City, California, said on April 13 that it intended to submit a new drug application under the Commissioner’s National Priority Voucher pilot program.

For patients, the distinction between regulatory access and real-world access is stark. Expanded access can widen the path to treatment, but it does not settle how broadly the drug will be available, what it will cost, or how quickly oncologists will embrace it as standard care. That larger question now rests on whether regulators ultimately approve the medicine and whether payers and hospitals can support its use at scale.

Brian M. Wolpin, the Harvard Medical School and Dana-Farber Cancer Institute pancreatic cancer specialist who served as principal investigator for the Phase 3 trial, called the results a “clear and highly meaningful step forward” for patients who progressed after prior treatment, usually chemotherapy.

The pressure behind the data is personal as well as clinical. Former Sen. Ben Sasse, 54, learned he had metastatic pancreatic cancer in December 2025 and said doctors initially told him he had only three to four months to live. He called daraxonrasib “a miracle drug,” describing the trial as the best, and perhaps only, path forward.