
The CHMP backed RASONQUE for eligible patients, while final marketing authorization now awaits a European Commission decision.
Revolution Medicines said the European Medicines Agency’s CHMP has recommended RASONQUE for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. The European Commission must still decide whether to grant marketing authorization.
The recommendation is based on the Phase 3 RASolute 302 trial. In the overall study population, RASONQUE reduced the risk of death by 60% compared with chemotherapy, the company said.
As of 14:36 UTC on Thursday, Revolution Medicines shares traded at $191.69, down 0.95% since the previous close.
This article was produced with the help of AI technology. Based on reporting by the outlets listed above.