On May 1, 2026 The U.S. Food and Drug Administration (FDA) reported it 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).

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The EAP is intended to provide treatment access in a controlled and monitored setting, consistent with FDA regulations governing investigational medicines.

Revolution Medicines commends the FDA’s expedited review and continued commitment to providing a pathway for patients with life-threatening diseases to access investigational therapies outside of a clinical trial when no comparable or satisfactory alternative treatment options are available.

This authorization represents a critical step in the process of opening an EAP. Revolution Medicines is moving as quickly as possible to ensure safe and equitable access to daraxonrasib for eligible patients in the United States.

Per FDA regulations governing expanded access programs, Revolution Medicines is not able to accept requests directly from patients or caregivers. All requests for expanded access must be initiated by a licensed treating physician.

For additional information regarding this EAP or for other questions regarding Revolution Medicines investigational agents, physicians may contact: [email protected]

(Press release, Revolution Medicines, MAY 1, 2026, View Source [SID1234665009])