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 Overview

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

Expanded Access Program

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.

Hope for Patients

“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.

Positive Trial Results

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.

Future Directions

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.

AI in Early Detection

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.

Disclaimer: This content is for informational purposes only and does not constitute medical advice. Always consult a healthcare professional for health-related questions or concerns.

Fuente: https://www.epocrates.com/online/article/fda-clears-expanded-access-for-promising-pancreatic-cancer-drug