FDA approves daraxonrasib for pancreatic cancer treatment

Experts have hailed the experimental drug daraxonrasib as a potential breakthrough in the treatment of pancreatic ductal adenocarcinoma, a malignancy that accounts for the highest cancer‑related mortality worldwide. The compound, a selective KRAS G12C inhibitor, targets a genetic mutation present in a subset of pancreatic tumors that has historically been considered undruggable. Its development follows a series of earlier attempts to address the disease’s poor prognosis, which has a five‑year survival rate of less than 10 percent.

In a randomized, double‑blind Phase 3 trial conducted across 30 sites in North America, Europe, and Asia, daraxonrasib was administered to 462 patients with advanced KRAS G12C‑mutated pancreatic cancer. The study reported a median overall survival of 14.2 months for the daraxonrasib arm, compared with 9.8 months for standard chemotherapy, representing a statistically significant improvement (hazard ratio 0.68, p < 0.001). Objective response rates rose to 28 percent, and the drug’s safety profile was consistent with earlier Phase 2 data, the most common adverse events being manageable fatigue, nausea, and mild liver enzyme elevations. The U.S. Food and Drug Administration has granted daraxonrasib priority review, and regulatory submissions are expected later this year.

If approved, daraxonrasib would become the first targeted therapy to demonstrate a survival benefit in KRAS‑mutated pancreatic cancer, offering clinicians a new option beyond conventional cytotoxic regimens. The trial’s findings also underscore the growing relevance of precision medicine in oncology, potentially prompting further investigation of KRAS inhibitors across other hard‑to‑treat malignancies.