FDA approves Revolution Medicines pancreatic cancer drug Rasonque

The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor developed by Revolution Medicines, Inc., for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.

Rasonque is a once-daily tablet that targets multiple forms of the RAS protein, which drives tumor growth in most patients with pancreatic adenocarcinoma. In a randomized, open-label, multicenter clinical trial of 500 adults with previously treated metastatic pancreatic adenocarcinoma, Rasonque improved median overall survival to 13.2 months, compared to 6.7 months for standard chemotherapy.

The approval was granted 6.5 months before the user fee deadline, according to Angelo de Claro, M.D., director of the FDA's Oncology Center of Excellence.

Pancreatic adenocarcinoma accounts for approximately 90% to 95% of the roughly 67,000 new pancreatic cancer cases diagnosed annually in the United States, according to the National Cancer Institute. Despite representing about 3.2% of all cancer diagnoses, the disease accounts for a disproportionately high share of cancer deaths.

The FDA granted Rasonque Breakthrough Therapy and Orphan Drug designations, and the application received Priority Review. It was also reviewed under the Commissioner's National Priority Voucher pilot program. Common side effects include rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.

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