AMSTERDAM — People in Europe whose pancreatic cancer has spread and outlasted their first chemotherapy may soon have an oral pill to ask their oncologists about. On Thursday the European Medicines Agency said its human medicines committee had recommended Rasonque, known generically as daraxonrasib, for adults with metastatic pancreatic adenocarcinoma who have had at least one earlier treatment.
The speed stands out. The agency said its review began in early July and took under 150 days, against a standard evaluation that can run up to 210 active days and usually takes about a year once company response time is counted. In August the FDA approved daraxonrasib for a similar group of patients in the United States, with Revolution Medicines as the sponsor on both sides of the Atlantic.
A committee opinion is not a licence. The EMA called it an “intermediary step”: the opinion now goes to the European Commission, which the agency says will fast-track an EU-wide decision. Price and reimbursement are then settled separately in each member state, so a patient in Lyon and one in Lodz may not wait the same time.
The evidence rests on one trial, and the numbers carry rough edges. The EMA reported that among 500 previously treated patients in an open-label phase 3 study, 92 percent of them with a RAS G12 mutation, those given Rasonque lived a median 12.4 months against 6.7 months on chemotherapy. Median time without disease worsening was 7.2 months against 3.6.
That 12.4 months is lower than the 13.2 months the FDA cited in August. The New England Journal of Medicine abstract also gives 13.2 months for the overall trial population, with a hazard ratio for death of 0.40. The EMA says its survival analysis used data collected up to 15 June 2026, while progression was analysed on data up to 10 February 2026. Neither the EMA notice nor the FDA announcement explains how the two survival figures relate.
The side effects the EMA lists as most common are diarrhoea, rash, stomatitis, which is inflammation of the lining of the mouth, nausea and vomiting. In the journal’s report, grade 3 or higher adverse events occurred in 61.8 percent of patients on daraxonrasib and 69.6 percent on chemotherapy, and treatment-related events led 1.2 percent of the daraxonrasib group to stop, against 11.2 percent on chemotherapy. The study was funded by Revolution Medicines.
The FDA said it approved the drug 6.5 months before its user-fee deadline, after clearing an early-access pathway for daraxonrasib in May. In Europe the drug was designated an orphan medicine in April, and the EMA says it will now review whether that status can be maintained.
Revolution Medicines’ own statement on the opinion could not be retrieved for this report. The EMA’s notice gives no European price and no date for the Commission’s ruling, and what a patient in any member state will pay, or when a first prescription could be written, is not in it.
