European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process
The European Medicines Agency (EMA) has initiated a phased review of Revolution Medicines' lead asset daraxonrasib for pancreatic cancer, aiming to accelerate assessment ahead of a full marketing authorization application. This regulatory milestone follows positive results from the pivotal Phase 3 RASolute 302 trial, which showed unprecedented improvements in overall survival and progression-free survival compared to standard chemotherapy. Simultaneously, the company’s rolling New Drug Application (NDA) submission to the U.S.
Key figures
- Drug Name
- daraxonrasib
- Phase Of Trial
- Phase 3
- Ema status
- phased review started
- Fda status
- rolling NDA submission nearing completion
- Indication
- pancreatic cancer (PDAC)
- Trial name
- RASolute 302
AI analysis
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