FDA Approves Daraxonrasib Expanded Access in Two Days — Pancreatic Cancer

On April 28, the FDA received Revolution Medicines' expanded access application for daraxonrasib and approved it in 30 days—effectively expedited handling in just two days. Based on clinical data showing 60% reduction in mortality risk versus chemotherapy in previously treated metastatic pancreatic cancer, the turnaround was exceptionally fast. The same day, Scancell's iSCIB1+ melanoma immunotherapy also received fast-track designation.