Cancer
EMA recommends Rasonque for metastatic pancreatic cancer
EMA’s committee recommended EU authorisation for Rasonque in adults whose metastatic pancreatic cancer worsened after prior treatment.
The recommendation is an intermediary step. The European Commission will make the decision on EU-wide authorisation.
EMA said its recommendation followed a phased review that began in early July 2026 and took less than 150 days. The review assessed data as the company submitted them.
In an open-label, phase 3 multinational study of 500 patients, those treated with Rasonque lived a median of 12.4 months, compared with 6.7 months for those treated with chemotherapy. Median time without disease worsening was 7.2 months with Rasonque and 3.6 months with chemotherapy. EMA said the most common side effects reported were diarrhoea, rash, stomatitis, nausea and vomiting. If authorised, pricing and reimbursement decisions will be made by each EU member state.
