Revolution Medicines' Pancreatic-Cancer Drug Cleared for Expanded Access

By Elias Schisgall

Revolution Medicines received a "safe to proceed" letter from the Food and Drug Administration, allowing the pharmaceutical company to launch an expanded-access treatment protocol for its pancreatic-cancer treatment.

The letter will allow the company to initiate an EAP for daraxonrasib, an investigational RAS(ON) inhibitor, for patients with metastatic pancreatic ductal adenocarcinoma who have already received treatment.

"This authorization represents a critical step in the process of opening an EAP," the company said. "Revolution Medicines is moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients in the United States."

The FDA said it received a request for the company for expanded access on Tuesday, and granted the request Thursday.

"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," FDA Commissioner Marty Makary said.

Daraxonrasib has already received a national-priority voucher and breakthrough-therapy and orphan-drug designations from the FDA. The company has said it intends to submit a new-drug application under the Commissioner's National Priority Voucher pilot program.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

May 01, 2026 13:15 ET (17:15 GMT)