The U.S. Food and Drug Administration has authorized an expanded access program for daraxonrasib, an experimental treatment for patients with previously treated metastatic pancreatic cancer. The decision follows strong results from the Phase 3 RASolute 302 trial.
The study showed that daraxonrasib significantly improved survival compared with standard chemotherapy. The drug reduced the risk of death by 60% and extended median overall survival to 13.2 months, compared to 6.7 months with chemotherapy. It was also generally well tolerated, with no new safety concerns reported.
The FDA approved the expanded access request in just two days, reflecting the urgent need for better pancreatic cancer treatments. The drug has received Breakthrough Therapy and Orphan Drug designations and is being fast-tracked through a priority review program.
The trial included patients with RAS mutations as well as some without them. Lead investigator Brian Wolpin said the results could change treatment standards for patients whose cancer has progressed after chemotherapy. The developer plans to seek full FDA approval soon.