Revolution Medicines : Statement on FDA Expanded Access Authorization for Daraxonrasib in Patients with Previously Treated Metastatic Pancreatic Cancer
RVMD
Published on 05/01/2026 at 11:07 am EDT
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 daraxonrasib, an investigational RAS(ON) inhibitor, in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).
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]
About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Additional development opportunities in the company's pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit https://www.revmed.com and follow us on LinkedIn.
Revolution Medicines Media & Investor Contact: [email protected] [email protected]
Disclaimer
Revolution Medicines Inc. published this content on May 01, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 01, 2026 at 15:06 UTC.