The European Medicines Agency's medicines committee recommended Rasonque on October 15, 2026, for adults with metastatic pancreatic adenocarcinoma after at least one systemic treatment. The positive opinion on Revolution Medicines' daraxonrasib is a step toward European Union authorization; a European Commission decision is still required.
According to the EMA, the medicine blocks RAS signalling that supports cancer growth. The company describes it as a once-daily oral treatment used on its own. Its proposed European use covers previously treated patients whose cancer has spread, rather than all patients with pancreatic cancer.
The FDA's account of the RASolute 302 study describes 500 patients randomly assigned to daraxonrasib or chemotherapy after their disease progressed following one treatment line. In the primary analysis, median overall survival was 13.2 months with daraxonrasib and 6.7 months with chemotherapy. Median survival without disease progression was 7.2 and 3.6 months, respectively.
Revolution Medicines also reported a later, ad hoc analysis in which median overall survival was 12.4 months with the drug and 6.7 months with chemotherapy. That distinction matters when interpreting the earlier figures: these are results for study groups, not a prediction of how long an individual patient will live. The company said the EMA used an expedited phased review under its Cancer Medicines Pathfinder project.
The EMA lists rash, diarrhoea, inflammation of the mouth, nausea and vomiting among the most common side effects, and says experienced cancer physicians should initiate treatment. The FDA, which approved daraxonrasib on August 26, also lists warnings including gastrointestinal perforation, lung inflammation and harm to a developing fetus. The survival benefit therefore comes alongside risks requiring clinical oversight.
The next regulatory step is consideration by the European Commission. The EMA says detailed prescribing recommendations will appear in all official EU languages after authorization. The October recommendation advances the approval process, but does not itself establish a European launch date or immediate availability for patients.
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