The European Medicines Agency said on Thursday its human medicines committee has recommended granting a marketing authorisation for Rasonque (daraxonrasib), an oral RAS inhibitor from Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma whose disease has progressed after at least one previous treatment. In the open label phase 3 study of 500 patients, 92 percent of them with confirmed RAS G12 mutations, median overall survival was 12.4 months on Rasonque against 6.7 months on chemotherapy, and median progression free survival was 7.2 months against 3.6 months. The drug was reviewed under the agency’s Cancer Medicines Pathfinder phased review, which cut assessment time to under 150 days, and the opinion now goes to the European Commission, which will fast track the EU wide authorisation decision.
EMA backs Revolution Medicines pancreatic cancer drug Rasonque
The European Medicines Agency's CHMP has recommended authorising Rasonque (daraxonrasib), from Revolution Medicines, for adults with metastatic pancreatic cancer who have had at least one prior treatment.
Why it matters: Patients in the phase 3 trial lived a median 12.4 months on the drug against 6.7 months on chemotherapy, a rare survival gain in one of oncology's hardest indications, and the opinion now goes to the European Commission for a fast tracked decision.
Data as of EMA CHMP opinion published Thursday, October 15, 2026, read in full at the regulator. Trial figures are the agency's summary of the applicant's phase 3 data. Developing item.
Sources
- EMA recommends authorisation of Rasonque for metastatic pancreatic cancer · European Medicines Agency · 2026-10-15