Overview
- The European Medicines Agency’s CHMP began a phased rolling review of daraxonrasib on Tuesday, July 7, to assess quality, safety and clinical data as they are submitted.
- The U.S. Food and Drug Administration enabled expanded access pathways in May, and several U.S. centers including HonorHealth and Memorial Regional Hospital have launched physician‑led programs to give the pill to eligible patients.
- Late‑stage trial results presented at ASCO and published in The New England Journal of Medicine showed median overall survival of 13.2 months on daraxonrasib versus 6.7 months on chemotherapy in previously treated metastatic pancreatic cancer, and the drug targets mutated KRAS proteins.
- Access remains uneven outside the United States because Revolution Medicines has not opened broad programs abroad; Health Canada said the company declined individual import requests under its Special Access Program, though the company plans to open Canadian trial sites soon.
- If regulators complete reviews quickly, daraxonrasib could change care for a cancer driven by KRAS mutations, but rolling reviews do not lower safety standards and could create high demand and logistical strain on hospitals and trial networks.