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FDA green lights early access to pancreatic cancer drug, daraxonrasib
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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
FDA green lights early access to pancreatic cancer drug, daraxonrasib
May 1, 2026, 2:24 p.m. ETThe Food and Drug Administration on May 1 said it will grant some patients early access to Revolution Medicines' experimental pancreatic cancer drug daraxonrasib.Daraxonrasib has not yet been approved by the FDA, but the company released promising late-stage clinical trial results in April for patients with pancreatic cancer that had spread to other parts of the body.The FDA told the Redwood City, California-based company that it can begin an "expanded access treatment protocol" for some patients who had previously been treated for pancreatic cancer.The FDA said it received the expanded access request from Revolution Medicines for daraxonrasib on April 28 and approved it on April 30.Pancreatic cancer is among the most deadly forms of cancer. Estimates show more than 52,000 people will die from pancreatic cancer in 2026, a disease that accounts for 8% of all cancer deaths, according to the National Cancer Institute.About 3% of people will survive five years after diagnosis if pancreatic cancer has spread to distant parts of the body, NCI statistics show.On April 13, Revolution Medicines released clinical trial results of patients with pancreatic cancer that had spread to other parts of the body. The trial showed patients who took
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