FDA Opens Early Access to Novel Pancreatic Cancer Drug Generating Buzz

— Requests for treatment with daraxonrasib must come from licensed U.S. physicians May 1, 2026 • 2 min read The FDA has given the green light to an expanded access program (EAP) for the investigational pancreatic cancer drug daraxonrasib. In a "safe to proceed" letter to Revolution Medicines, the FDA gave its approval to initiate the EAP in collaboration with licensed prescribers. The approval came just 2 days after the FDA received the company's application for an EAP. "Granting the request 2 days after receiving the expanded access application reflects the FDA's strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer," FDA Commissioner Marty Makary, MD, MPH, said in a statement. "Having taken care of many patients with metastatic cancer, I am hopeful that today's action will improve the lives of patients suffering from this disease." The EAP approval for daraxonrasib continues a string of good news that began just 3 weeks ago when the company announced an "unprecedented" improvement in overall survival with the RAS inhibitor in patients with previously treated metastatic pancreatic cancer. Median OS essentially doubled from 6.7 months with standard therapy to 13.2 months with daraxonrasib. A week later