Rasonque (daraxonrasib) wins FDA approval in 40 days under Commissioner's National Priority Voucher

Rasonque (daraxonrasib) received FDA approval for second-line metastatic pancreatic cancer just 40 days after formal acceptance, 203 days ahead of its PDUFA goal date. The review used the Commissioner's National Priority Voucher (CNPV), an accelerated pilot mechanism FDA launched in June 2025 that breaks the traditional review framework used for decades.