The FDA has approved Revolution Medicines’ daraxonrasib (Rasonque) for advanced pancreatic ductal adenocarcinoma, marking the first approval of a drug specifically targeting a genetic driver in the disease. The decision, announced this week, covers second-line patients with advanced pancreatic cancer. The approval is backed by a practice-changing Phase 3 program previously reported earlier this year, where daraxonrasib showed median overall survival of 13.2 months versus 6.7 months with standard chemotherapy in the studied patient population. Analysts expect the near-term launch to quickly reshape the competitive treatment landscape for metastatic pancreatic cancer. Revolution Medicines positioned daraxonrasib as an all-oral option intended to extend survival for patients with limited choices after chemotherapy. Following FDA review, clinicians now have a targeted mechanism to deploy in settings where traditional regimens have struggled. Separately, the approval reinforces growing regulatory momentum for mechanism-first oncology therapies delivered on accelerated timelines and supported by biomarker-defined trial designs.