EMA committee backs Revolution Medicines' Rasonque for metastatic pancreatic cancer

What's the news? The European Medicines Agency's human medicines committee (CHMP) has adopted a positive opinion recommending European Union marketing authorisation for Rasonque (daraxonrasib), an oral once-daily RAS inhibitor from Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma (pancreatic cancer that has spread) who have already had at least one previous treatment. The positive opinion, announced 15 October 2026, is the last step before the European Commission issues a final, fast-tracked decision on EU-wide authorisation.

Why it matters: RAS proteins are molecular switches that help cells grow and divide; mutations in the RAS gene keep these switches permanently on, driving many cancers. Rasonque is designed to block the RAS protein directly and, if the Commission approves it, would be the first broad RAS-targeted treatment available in the EU for metastatic pancreatic cancer — a disease with very few options after first-line therapy. The opinion is based on the Phase III RASolute 302 trial, in which daraxonrasib extended median overall survival to 13.2 months versus 6.7 months with the investigator's choice of chemotherapy. The medicine already received U.S. FDA approval in August 2026.

Read more: Revolution Medicines, 15 Oct 2026 · European Medicines Agency, 15 Oct 2026