FDA clears Rasonque, first RAS inhibitor for metastatic pancreatic cancer

The FDA has approved Rasonque (daraxonrasib), a once-daily tablet from Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma who have already had at least one systemic therapy or cannot tolerate multidrug regimens. It is the first approved drug in its class to target RAS, a protein that drives tumor growth in most pancreatic cancers. In a 500-patient randomized trial, it extended median overall survival to 13.2 months versus 6.7 months for standard chemotherapy — a meaningful gain in a disease with historically dismal outcomes.

Pancreatic adenocarcinoma accounts for 90–95% of the roughly 67,000 U.S. pancreatic cancer diagnoses each year and causes a disproportionate share of cancer deaths due to late detection and aggressive progression. Common side effects include rash, diarrhea, mouth inflammation, nausea, fatigue, and bleeding.

The regulatory story is the notable angle for a policy audience: the FDA granted the drug Breakthrough Therapy and Orphan Drug designations plus Priority Review, and ran it through the new Commissioner’s National Priority Voucher pilot, clearing it about 6.5 months ahead of the user-fee deadline. The agency framed the speed as evidence of an effort to compress review timelines for therapies addressing serious unmet needs.