FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer

The FDA approved Rasonque (daraxonrasib), a once-daily RAS inhibitor, for adults with metastatic pancreatic adenocarcinoma who have received prior systemic therapy or cannot receive multi-agent regimens. In a 500-patient trial, it extended median overall survival to 13.2 months versus 6.7 months with standard chemotherapy. The drug received Breakthrough Therapy, Orphan, and Priority Review designations, with common adverse events including rash, diarrhea, nausea, and fatigue.