The FDA has approved Revolution Medicines’ daraxonrasib (Rasonque), a two-pills-a-day targeted treatment for metastatic pancreatic cancer patients whose disease has progressed after chemotherapy. The approval expands options in a setting where standard regimens often fail after initial benefit, and durable responses are uncommon. In the pivotal Phase 3 trial reported earlier this year, daraxonrasib delivered a median overall survival of 13.2 months in patients with relevant gene mutations, compared with 6.6 months with chemotherapy. Across all trial participants, median overall survival was 13.2 months versus 6.7 months, reinforcing the label’s potential to shift treatment sequencing. Revolution Medicines’ next challenge will be translating the trial’s mutation-enriched outcomes into real-world effectiveness, including patient selection and access. The agency’s decision immediately places Rasonque into competitive second-line and broader second-line decision pathways for advanced pancreatic cancer.