U.S. Food and Drug Administration (FDA) Approves Daraxonrasib for Metastatic Pancreatic Cancer

Key facts

• The U.S. Food and Drug Administration (FDA) approved daraxonrasib, an oral multi-selective RAS(ON) inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
• Daraxonrasib is the first approved RAS-targeted therapy for pancreatic cancer.
• The approval was based on the phase 3 RASolute 302 trial, which showed that daraxonrasib reduced the risk of death by 60% compared to chemotherapy (hazard ratio 0.40).
• In the trial, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy, and median progression-free survival was 7.2 months versus 3.6 months.
• The most common side effects of daraxonrasib were rash, inflammation in the mouth, nausea, and diarrhea.