FDA grants early approval to RevMed's pancreatic cancer drug Rasonque

FDA granted early approval to Revolution Medicines' daraxonrasib, now named Rasonque, for pancreatic adenocarcinoma, arriving 6.5 months before the FDA deadline.

The oral RAS inhibitor demonstrated a marked survival benefit in the Phase 3 RASolute 302 trial, achieving a median overall survival of 13.2 months versus 6.7 months for standard chemotherapy.

The agency also assigned several expedited designations, including the Commissioner’s National Priority Voucher, providing patients with a new option in a disease that has a five‑year survival rate of about 13%.