FDA Approves Expanded Access Treatment Protocol for Pancreatic Cancer Drug

The drug inhibits a protein that is mutated in most pancreatic cancer tumors.

May 5, 2026

Key Highlights

The FDA issued a 'safe to proceed' letter to Revolution Medicines for their experimental pancreatic cancer drug, daraxonrasib.
The expanded access protocol targets patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
The FDA's rapid approval process demonstrates a strong commitment to early access for serious and life-threatening conditions.
Daraxonrasib is a RAS inhibitor designed to target a mutated protein common in pancreatic tumors.
Revolution Medicines submitted the expanded access request on April 28, and the FDA responded by April 30.

The FDA has announced that a “safe to proceed” letter has been issued to Revolution Medicines, allowing them to “initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug.”

The EAP is for “patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The FDA received the expanded access request from Revolution Medicines on April 28 and signed it on April 30.”

FDA commissioner Marty Makary touted the quick turnaround on the expanded access application as proof of the FDA’s “strong commitment to facilitate early access to therapies for serious and life-threatening conditions.”

The drug, called daraxonrasib, is a “RAS inhibitor designed to inhibit a protein that is mutated in most pancreatic cancer tumors.”