FDA clears expanded access for promising pancreatic cancer drug

FDA has issued a “safe to proceed” letter authorizing expanded access to the investigational pancreatic cancer therapy daraxonrasib for patients with previously treated metastatic pancreatic ductal adenocarcinoma.

Daraxonrasib, also known as RMC‑6236, is a RAS inhibitor designed to target mutant RAS proteins, which are present in most pancreatic cancer tumors.

Under FDA rules, expanded access permits use of investigational drugs outside clinical trials for serious or life‑threatening conditions when no comparable alternatives are available. Requests are made by U.S.-licensed physicians through the sponsor.

“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,” said FDA Commissioner Marty Makary, MD, MPH.

The expanded access decision follows previously reported positive phase 3 data showing once‑daily, oral daraxonrasib significantly improved overall and progression‑free survival vs. standard IV chemotherapy in previously treated metastatic pancreatic cancer.

Revolution Medicines has stated it plans to submit a new drug application for daraxonrasib under the FDA Commissioner’s National Priority Voucher pilot program. The therapy was granted a national priority voucher in October 2025 and has also received FDA Breakthrough Therapy and Orphan Drug designations.

In recent related research, an AI‑based CT imaging model may eventually enable earlier detection of pancreatic ductal adenocarcinoma, potentially identifying disease before advanced stages such as those targeted by expanded access programs.

Source: U.S. Food and Drug Administration. (2026, May 1). News release. FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug