The FDA has approved Revolution Medicines’ daraxonrasib (Rasonque) for advanced pancreatic ductal adenocarcinoma, marking the first approved RAS inhibitor for this indication. The approval covers patients with metastatic disease whose cancer has progressed after prior chemotherapy. Revolution Medicines previously reported phase 3 data showing a median overall survival of 13.2 months with daraxonrasib versus 6.7 months with standard chemotherapy in the overall population, with similar results in the trial’s broader cohort. The drug is administered as a twice-daily, oral regimen. Industry analysts framed the decision as a potential shift in treatment sequencing for a cancer with limited options and historically poor outcomes. PDUFA timing and review pace were highlighted in concurrent coverage as notably fast for a program of this type. The FDA’s nod also reinforces momentum for precision oncology approaches built around specific molecular drivers in pancreatic cancer, where targeted therapies have struggled to demonstrate consistent benefit.
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