FDA approves Rasonque, first treatment to broadly target RAS in metastatic pancreatic cancer

On August 26, FDA approved Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The recommended dose is 300 mg orally once daily until disease progression or unacceptable toxicity.

The approval opens a new treatment pathway in a disease in which RAS alterations drive tumor growth in most patients but have long been difficult to target directly. Daraxonrasib is a first-in-class RAS(ON) inhibitor that blocks active RAS signaling across multiple variants rather than targeting a single KRAS mutation. The indication does not require selection for a particular RAS alteration, potentially making targeted therapy available to a broader group of patients.

In the randomized, open-label phase 3 RASolute 302 trial, 500 adults with previously treated metastatic pancreatic adenocarcinoma received daraxonrasib or physician’s choice of chemotherapy. Median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy, corresponding to a 60% lower risk of death. Median progression-free survival was 7.2 versus 3.6 months, and objective response rates were 30% and 11%, respectively.

Benefits were demonstrated in patients whose tumors had a RAS G12 mutation and separately in the overall trial population, which also included patients without a RAS G12 mutation. Grade 3 or higher adverse events occurred in 61.8% of patients receiving daraxonrasib and 69.6% receiving chemotherapy.

Common adverse reactions include rash, diarrhea, stomatitis, nausea, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. Warnings include severe dermatologic and soft-tissue toxicity, gastrointestinal perforation, and interstitial lung disease or pneumonitis.

“This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, MD, director of the FDA’s Oncology Center of Excellence.

Source: FDA. (2026 Aug 26). FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma