Revolution Medicines' NDA For Daraxonrasib Accepted By FDA For Metastatic Pancreatic Cancer

India, July 22 -- Revolution Medicines, Inc. (RVMD) announced that the U.S. FDA has accepted for review its New Drug Application (NDA) for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for patients with metastatic pancreatic ductal adenocarcinoma.

Metastatic pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive cancers, often linked to mutations in the RAS gene family. Daraxonrasib is designed to inhibit RAS, the primary driver of pancreatic cancer, and the application is supported by results from the Phase 3 RASolute 302 trial.

This global, randomized study compared Daraxonrasib to standard chemotherapy in previously treated metastatic PDAC patients, with or without identified RAS mutations. The trial met all p...