The U.S. Food and Drug Administration has cleared Revolution Medicines to initiate an expanded access program for daraxonrasib in previously treated metastatic pancreatic cancer patients.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration has issued a “safe to proceed” letter to Revolution Medicines, allowing the company to initiate an expanded access treatment protocol (EAP) for daraxonrasib, an investigational RAS(ON) inhibitor, in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
The authorization enables controlled and monitored access to daraxonrasib outside of a clinical trial setting, in line with FDA regulations governing investigational therapies. Expanded access programs are designed to provide treatment options for patients with serious or life-threatening conditions who lack satisfactory alternatives.
According to the FDA, the agency received the expanded access request on April 28 and signed it on April 30, reflecting an expedited two-day review timeline. The protocol applies to patients with previously treated metastatic PDAC, a population with limited therapeutic options.
Daraxonrasib (RMC-6236) is a RAS inhibitor designed to target mutations in the RAS protein, which are present in the majority of pancreatic cancer tumors. The drug is currently investigational and has not yet received full regulatory approval.
“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 Marty Makary, M.D., M.P.H. “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.”
Revolution Medicines indicated that this authorization represents an important step toward opening the EAP and that the company is working to enable safe and equitable access for eligible patients across the United States.
Under FDA regulations, expanded access requests cannot be made directly by patients or caregivers. Instead, licensed physicians must submit requests to the sponsor on behalf of eligible patients.
In parallel, Revolution Medicines has outlined broader regulatory plans for daraxonrasib. The company announced its intention to submit a new drug application under the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program.
The therapy received a national priority voucher in October 2025, along with prior Breakthrough Therapy and Orphan Drug designations, supporting its development in pancreatic cancer.
Reference
FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug | FDA
About the Writer
Samiksha Vikram Jadhav is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.