The US Food and Drug Administration (FDA) has approved Rasonque (daraxonrasib) for the treatment of adults with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
Pancreatic cancer frequently presents with a late diagnosis, aggressive biology, and limited response to conventional treatment options. RAS, a key growth control switch in human cells, is the main cause of pancreatic cancer, which is characterized by excessive RAS signaling. Approximately 90% to 95% of the 67,000 new cases of pancreatic cancer diagnosed in the United States each year are pancreatic adenocarcinoma. Despite representing roughly 3.2% of all cancer diagnoses, pancreatic adenocarcinoma accounts for a disproportionately high share of cancer deaths.
Daraxonrasib is a RAS inhibitor that targets multiple forms of the RAS protein.
In the phase 3 randomized, open-label, multicenter RASolute 302 clinical trial, 500 adults with previously treated metastatic PDAC, received either daraxonrasib or investigator’s choice of cytotoxic chemotherapy. The trial met all primary and key secondary endpoints in both the RAS G12 mutant population and the overall intent-to-treat (ITT) population.
In the ITT population, daraxonrasib reduced the risk of death by 60% compared with chemotherapy and the median overall survival was 13.2 months compared to 6.7 months for chemotherapy. Statistically significant improvements were also observed in progression-free survival (PFS) with the median PFS of 7.2 months with daraxonrasib compared to 3.6 months with chemotherapy.
Additionally, the safety profile was deemed manageable and favorable. The most common adverse reactions in patients treated with daraxonrasib were rash, diarrhea, stomatitis, nausea, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.
Full results from the RASolute 302 trial were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting with simultaneous publication in The New England Journal of Medicine.
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