ema.europa.eu·· 4 hours agoPickScore90
EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
In brief
EMA's CHMP has recommended EU marketing authorisation for Revolution Medicines' Rasonque (daraxonrasib), an oral RAS inhibitor for adults with metastatic pancreatic adenocarcinoma previously treated at least once. In a 500-patient phase 3 study, median overall survival was 12.4 months versus 6.7 with chemotherapy, and median progression-free survival 7.2 versus 3.6 months. The European Commission will now fast-track its decision, with pricing left to Member States.
Why it matters
CHMP backing via a phased review under 150 days sets precedent for faster EU assessments of priority cancer medicines.
Source: ema.europa.eu · ema.europa.eu