FDA Approves Rasonque, First Targeted Therapy for Metastatic Pancreatic Cancer
The FDA approved Rasonque (daraxonrasib) on August 26 as the first RAS inhibitor for adults with metastatic pancreatic adenocarcinoma. In clinical trials, patients taking Rasonque lived a median of 13.2 months compared to 6.7 months on standard chemotherapy. The drug is taken as a once-daily oral tablet.
The U.S. Food and Drug Administration approved Rasonque (daraxonrasib) on August 26, 2026, making it the first targeted therapy of its class for adults with metastatic pancreatic adenocarcinoma.
Developed by Revolution Medicines, Rasonque is a first-in-class RAS inhibitor. The FDA granted approval 6.5 months ahead of the scheduled user fee deadline, reflecting the urgency of the need. Pancreatic cancer has historically had very limited treatment options.
The approval covers adult patients who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The drug is administered as a 300 mg once-daily oral tablet.
Clinical data from the Phase III RASolute 302 trial, which enrolled 500 participants, drove the approval. Patients taking Rasonque achieved a median overall survival of 13.2 months, compared to 6.7 months for those on standard chemotherapy. Progression-free survival was 7.2 months versus 3.6 months for the control group. The objective response rate was 30 percent in the Rasonque arm, compared to 11 percent with standard care.
The FDA used several expedited programs to facilitate the approval, including Priority Review, Breakthrough Therapy designation, and Orphan Drug designation. The review also used the Real-Time Oncology Review pilot program.
Common side effects include rash, stomatitis, diarrhea, nausea, fatigue, vomiting, abdominal pain, and edema. Revolution Medicines offers patient support through its (ON)Path program to help with side effect management and access.
