Accessing Daraxonrasib: A Quick Primer

Anne Weston, LRI, CRUK. Wellcome Images

Daraxonrasib has been all over the news, first with the report of the successful clinical trial and now with the announcement of expanded access.

But what does expanded access really mean, and how can patients get the drug, which is still not fully approved by the FDA? Let’s Win is here to break it down.

On May 1, 2026, the FDA announced that the investigational RAS(ON) inhibitor daraxonrasib would be available to patients with previously treated metastatic pancreatic cancer through its expanded access treatment protocol (EAP). Prior to this approval, daraxonrasib, developed by Revolution Medicines, was only available to patients through a clinical trial. With expanded access, patients who qualify can get the drug. However, the only way to apply is through a physician.

Daraxonrasib has caused significant excitement within the oncology community due to positive results from the phase III RASolute 302 trial. Patients with pretreated metastatic disease who received the once-a-day drug had a median overall survival of 13.2 months compared with 6.7 months for those receiving chemotherapy. Daraxonrasib was generally well tolerated, with manageable side effects and no unexpected health problems.

What is an EAP?

Similar to a clinical trial, the EAP for daraxonrasib has very specific criteria that patients must meet. Daraxonrasib is available to eligible adult patients with previously treated metastatic pancreatic cancer who have no comparable or satisfactory alternative therapy available to them and who are unable to participate in an ongoing clinical trial. More specific requirements are outlined at the EAP page on the ClinicalTrials.gov website.

Accessing Daraxonrasib

Because of the demand for this drug, Revolution Medicines has created an outline of its EAP. The first step in getting daraxonrasib is to talk to your treating physician about your eligibility.

If your doctor believes you are eligible, he or she must request the drug from Revolution Medicines. Once that request is made, your physician will be contacted directly by the company and asked to provide required information and complete necessary forms. Patients cannot file a request on their own—all requests must come from a physician.

The company also notes that the EAP may be limited by regulatory requirements, supply availability, and clinical trial considerations. Each request will be evaluated on a case-by-case basis. And Revolution Medicines retains discretion to approve or deny requests in accordance with applicable laws and regulations. 

A Major Win

To call this a major win for patients isn’t an overstatement, says gastrointestinal oncologist Allyson Ocean, M.D., Director, Pancreatic Cancer Research Program; Director, Hereditary Gastrointestinal Cancer Program, The Englander Institute of Precision Medicine; and Professor of Clinical Medicine at Weill Cornell Medicine, in New York City. She is also the Chair of the Let’s Win Scientific Advisory Board.

“If you treat pancreatic cancer patients you know that far too many present with metastatic disease, and once you exhaust standard-of-care there were not a lot of options for patients outside of a clinical trial,” Ocean explains. “This drug won’t work on every patient. No drug does. And this drug is not a cure. But for those patients that have a good response to it, daraxonrasib is a game changer.”

How do I find clinical trials?

Find a trial

It’s also important to know that this drug is just a first step, she adds. “There are a lot of companies working on KRAS in pancreatic cancer, so I strongly believe in the next few years we’re going to have even more good news for our patients,” Ocean notes.

Ongoing research by Revolution Medicines includes the RASolute 303 trial, which is evaluating daraxonrasib as a first-line treatment in metastatic pancreatic cancer. Another trial, RASolute 304, is evaluating the drug in patients who underwent surgery.

If you have any questions, don’t hesitate to reach out to Let’s Win.