The Priority Review

Approvals Brief

EMA recommends authorisation of Rasonque for metastatic pancreatic cancer

EMA's CHMP has recommended granting a marketing authorisation for Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior treatment. The recommendation follows a phased review that shortened assessment to less than 150 days, with Rasonque showing a median overall survival of 12.4 months versus 6.7 months for chemotherapy in a phase 3 study of 500 patients.

Primary source

EMA news release, October 15, 2026

EMA recommends authorisation of Rasonque for metastatic pancreatic cancer

Read the source: EMA recommends authorisation of Rasonque for metastatic pancreatic cancer ema.europa.eu

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