FDA grants Breakthrough Therapy Designation to daraxonrasib

The FDA granted daraxonrasib Breakthrough Therapy Designation for previously treated patients with metastatic pancreatic ductal adenocarcinoma harbouring KRAS G12 mutations.

On June 23, 2025 Revolution Medicines announced that the U.S. FDA had granted daraxonrasib Breakthrough Therapy Designation for the treatment of previously treated patients with metastatic pancreatic ductal adenocarcinoma with KRAS G12 mutations.

Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious conditions when preliminary clinical evidence indicates substantial improvement over available therapy. The designation was based on data from the pancreatic cancer cohort of the Phase 1/2 RMC-6236-001 study.