European Medicines Agency launches accelerated review of Revolution Medicines' pancreatic cancer drug daraxonrasib

The European Medicines Agency (EMA) has initiated a rolling, phased review of daraxonrasib, an oral RAS(ON) inhibitor developed by Revolution Medicines for patients with metastatic pancreatic ductal adenocarcinoma. The drug, designated an orphan medicinal product and a high‑priority medicine under the EMA’s Cancer Medicines Pathfinder program, is being evaluated ahead of a formal marketing application to shorten its assessment timeline.

Phase 3 data from the RASolute 302 trial showed daraxonrasib nearly doubled median overall survival versus standard chemotherapy (13.2 months versus 6.7 months) and improved progression‑free survival and quality‑of‑life measures. The EMA’s expedited review follows the U.S. FDA’s recent decision to grant early access to the pill and the company’s near‑completion of a rolling New Drug Application submission to the FDA.

The EMA’s Committee for Medicinal Products for Human Use will assess quality, safety and efficacy data as it becomes available, with the same standards applied as in a conventional review, aiming to make the treatment available to patients more quickly.