The European Medicines Agency’s EMA expert committee CHMP recommends that Revolution Medicines’ Rasonque, daraxonrasib, be approved in the EU for adults with metastatic pancreatic cancer who have previously received at least one treatment.
The recommendation follows a stepwise review that shortened EMA’s active evaluation to less than 150 days. The application now proceeds to the European Commission for an expedited decision on marketing authorization.
In a phase 3 study of 500 patients, median overall survival was 12.4 months with Rasonque, compared with 6.7 months with chemotherapy. Median progression-free survival was 7.2 and 3.6 months, respectively.
Rasonque was approved by the US FDA in August.
