EMA Committee Recommends Pancreatic Cancer Medicine Rasonque for EU Authorisation

What was announced

On 15 October 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) backed marketing authorisation for Rasonque, developed by Revolution Medicines. The oral medicine, with the active substance daraxonrasib, is meant for adults with metastatic pancreatic adenocarcinoma whose condition has worsened after earlier whole-body therapy.

The review finished in under 150 days. The agency used a phased review under its Cancer Medicines Pathfinder project, evaluating quality, non-clinical and clinical data as the manufacturer submitted them. Normal evaluations run up to 210 active days and often take about a year.

Daraxonrasib is a RAS inhibitor. RAS proteins help cells grow and survive, but gene mutations can leave them permanently on. The medicine binds to cyclophilin A to make a complex that attaches to RAS proteins, blocking their activity. In an open-label phase 3 trial of 500 patients, those given Rasonque lived for a median of 12.4 months, compared to 6.7 months for those on chemotherapy. Median progression-free survival was 7.2 months versus 3.6 months. Common reported side effects included diarrhoea, rash, stomatitis (mouth lining inflammation), nausea and vomiting.

What it means

The recommendation passes to the European Commission, which will fast-track an EU-wide marketing decision. A positive decision by the Commission provides the regulatory permit to sell the medicine throughout the bloc.

Patients will not get access right away. Each EU member state determines its own pricing and reimbursement rules based on its domestic health system. Separately, the drug falls under the EU Health Technology Assessment Regulation, meaning a joint clinical assessment coordinated by the European Commission's HTA Secretariat will take place independently of the licensing review.

What the announcement does not tell us

The announcement does not state when the European Commission will issue its final marketing ruling. It does not provide any information on the expected price of Rasonque or which national health services will agree to pay for it.

In addition, the agency gives no figures on how many patients experienced each side effect, nor does it detail severe reactions or trial dropouts. Finally, the text does not say whether Rasonque showed equal benefit across different patient subgroups within the 500-person study.