The U.S. Food and Drug Administration (FDA) has issued a “safe to proceed” letter to Revolution Medicines, allowing the company to initiate an expanded access treatment protocol (EAP) for its investigational pancreatic cancer drug daraxonrasib. This authorization enables patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) to access the drug outside of clinical trials.
The FDA received the expanded access application from Revolution Medicines on April 28, 2026, and granted approval just two days later on April 30, signaling expedited regulatory responsiveness for this serious condition. Under FDA regulations, expanded access permits investigational drugs to be used for treatment purposes in larger patient populations when submitted via a treatment protocol or investigational new drug application. Eligible patients must be referred by licensed U.S. physicians through the sponsor’s expanded access program.
FDA Commissioner Dr. Marty Makary emphasized the agency’s commitment to facilitating early access to treatments for life-threatening illnesses such as pancreatic cancer, stating the expedited approval reflects this priority. Daraxonrasib targets RAS, a protein mutated in most pancreatic tumors, by acting as a RAS inhibitor to disrupt cancer growth.
Revolution Medicines plans to submit a new drug application for daraxonrasib under the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program. The drug was awarded this priority voucher in October 2025 and has previously received Breakthrough Therapy and Orphan Drug designations, reflecting its potential to address an unmet medical need.
Why it matters
Pancreatic cancer, particularly metastatic PDAC, has limited treatment options and poor survival rates. The FDA’s expanded access approval provides patients with a new potential therapy while formal FDA review continues. Early access to investigational drugs like daraxonrasib can offer hope for those who have exhausted existing treatments.
Background
Daraxonrasib (also known as RMC-6236) is an experimental drug designed to inhibit aberrant RAS protein signaling, a key driver in pancreatic tumor growth. The FDA’s Breakthrough Therapy and Orphan Drug designations aim to expedite the development and review of treatments for serious or rare diseases. Expanded access programs allow patients who do not qualify for clinical trials to receive investigational therapies under controlled circumstances.
Sources
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