FDA Accepts New Drug Application for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer

Clinical Summary: 

• Design/Population: The FDA accepted for review a New Drug Application for daraxonrasib for adults with previously treated metastatic pancreatic ductal adenocarcinoma. The application is supported by findings from the global phase 3 RASolute 302 trial comparing daraxonrasib with investigator's choice of standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma. 
• Key Outcomes: RASolute 302 met all primary and key secondary end points, demonstrating improvements in overall survival and progression-free survival versus chemotherapy. Daraxonrasib also showed a manageable safety profile and significantly delayed deterioration in cancer-related pain, global health status, and quality of life.
• Clinical Relevance: FDA acceptance could expand targeted treatment options for patients with previously treated metastatic pancreatic ductal adenocarcinoma if approved.

The US Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for daraxonrasib (Revolution Medicines) for the treatment of adults with previously treated metastatic pancreatic ductal adenocarcinoma. The application is supported by findings from the global phase 3 RASolute 302 trial.

In the trial, patients with metastatic pancreatic ductal adenocarcinoma harboring a broad range of RAS variants, including RAS G12 mutations, as well as patients without an identified tumor RAS mutation, were randomized to receive either 300 mg of once daily daraxonrasib or investigator's choice of 1 of 4 standard cytotoxic chemotherapy regimens. The dual primary end points were progression-free survival (PFS), as assessed by blinded independent central review, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary end points included PFS and OS in the intent-to-treat population, objective response rate (ORR), duration of response, and patient-reported quality of life.

According to the company, daraxonrasib significantly improved OS and PFS compared with chemotherapy while delaying deterioration in cancer-related pain, overall global health status, and quality of life. Detailed efficacy and safety findings were previously presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The New England Journal of Medicine.

Daraxonrasib was selected for the FDA Commissioner's National Priority Voucher pilot program, which is intended to expedite the review of therapies addressing significant public health needs. The investigational agent has also received Breakthrough Therapy and Orphan Drug designations for previously treated metastatic pancreatic ductal adenocarcinoma. 

Outside the United States, the European Medicines Agency (EMA) has initiated a phased review of daraxonrasib through its marketing authorization process. The agent has also received orphan medicine designation for pancreatic cancer and high-priority status through the EMA Cancer Medicines Pathfinder program.

Daraxonrasib is an investigational oral RAS(ON) multi-selective inhibitor designed to inhibit signaling from both wild-type and mutant RAS proteins. In addition to metastatic pancreatic ductal adenocarcinoma, the agent is being evaluated in an ongoing global phase 3 development program in RAS-mutant non-small cell lung cancer and other RAS-driven malignancies.

Source: 

Revolution Medicines. Revolution Medicines’ New Drug Application for daraxonrasib accepted for review by US FDA for previously treated metastatic pancreatic cancer. Accessed on July 23, 2026. https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-new-drug-application-daraxonrasib-accepted