Revolution Medicines receives positive EU recommendation for RASONQUE
On October 15, 2026, the EMA’s CHMP issued a favorable recommendation for Revolution Medicines’ RASONQUE in adults with metastatic pancreatic adenocarcinoma previously treated with systemic therapy. In the Phase 3 RASolute 302 study, death risk was 60% lower with RASONQUE than with chemotherapy, while median overall survival was 13.2 months versus 6.7 months and median progression-free survival was 7.2 months versus 3.6 months. The recommendation still requires a European Commission decision before the drug can receive EU authorization.
Why it matters
The CHMP decision advances Revolution Medicines toward commercialization in Europe but does not yet authorize sales there. If the European Commission approves it, one centralized authorization would cover EU member states plus Iceland, Norway and Liechtenstein, while the United Kingdom and Switzerland would remain outside that process.
Key facts
- 1The EMA’s CHMP adopted a positive opinion for RASONQUE on October 15, 2026, following an expedited review under the Cancer Medicines Pathfinder project. stocktitan.net
- 2In the intent-to-treat population, RASONQUE produced a 60% reduction in the risk of death versus chemotherapy. stocktitan.net
- 3The trial reported median overall survival of 13.2 months with RASONQUE versus 6.7 months with chemotherapy, and median progression-free survival of 7.2 months versus 3.6 months. investing.com
- 4The U.S. Food and Drug Administration approved RASONQUE on August 26, 2026. stocktitan.net
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.