The US Food and Drug Administration has issued a ‘safe to proceed’ letter to Revolution Medicines, allowing the company to initiate an Expanded Access Protocol (EAP) for its investigational drug Daraxonrasib. The programme is designed to provide treatment access to patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), a highly aggressive and life-threatening form of cancer.

The FDA received the expanded access request on April 28 and approved it within two days, highlighting the agency’s expedited approach for serious conditions. Expanded access programmes allow eligible patients to receive investigational therapies outside of clinical trials, particularly when no satisfactory treatment options are available. Requests must be submitted by licensed physicians on behalf of patients.

Daraxonrasib is a RAS inhibitor that targets mutations commonly found in pancreatic tumours, aiming to disrupt cancer growth at its molecular source. The drug has already received Breakthrough Therapy and Orphan Drug designations from the FDA, reflecting its potential to address a critical unmet medical need.

Revolution Medicines has also indicated plans to submit a New Drug Application (NDA) for daraxonrasib under the Commissioner’s National Priority Voucher (CNPV) pilot programme. The therapy was granted a national priority voucher in October 2025, further underscoring its significance in oncology development.

Pancreatic cancer remains one of the deadliest cancers, with limited treatment options for advanced-stage patients. The FDA’s rapid approval of the expanded access protocol is expected to provide earlier access to promising therapies and improve outcomes for patients facing this challenging disease.