• Posted May 4, 2026

FDA Green Lights Expanded Access to Pancreatic Cancer Drug, Daraxonrasib

The U.S. Food and Drug Administration (FDA) granted expanded access for the use of an experimental pancreatic cancer drug, daraxonrasib. 

This means the drug will be available for early access to those who previously received conventional treatment for metastatic pancreatic ductal adenocarcinoma (PDAC). A healthcare provider must request access to the medication for their patient, according to an FDA statement. 

PDAC is an extremely aggressive form of pancreatic cancer with a five-year survival rate of only 3% for most patients. 

The FDA received the expanded access request from the drug’s manufacturer, Revolution Medicines, on April 28 and signed it April 30.

“Granting the request two 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,” said FDA Commissioner Dr. Marty Makary.

In trials, daraxonrasib was shown to double the average survival time for pancreatic cancer patients receiving conventional treatments, according toThe Washington Post. 

Patients in one trial had a median survival time of a little over 13 months (meaning half lived longer, half for a shorter time), compared to roughly six months on chemotherapy.

The FDA has marked the drug’s approval as the highest priority, and it could even come sometime next year, according to The Post.

“Revolution Medicines is moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients in the United States,” the company said in a statement Friday.

SOURCES: U.S. Food and Drug Administration, news release, May 1, 2026; The Washington Post, May 1, 2026