Revolution Medicines’ RASONQUE(™) (daraxonrasib) Receives Positive CHMP Opinion Recommending Marketing Authorization in European Union for Metastatic Pancreatic Cancer
Revolution Medicines' RASONQUE (daraxonrasib) received a positive CHMP opinion recommending EU marketing authorization for adults with metastatic pancreatic adenocarcinoma after at least one prior systemic therapy. The recommendation rests on the Phase 3 RASolute 302 trial, in which RASONQUE cut the risk of death by 60% versus chemotherapy (HR 0.40), with median overall survival of 13.2 months versus 6.7 months. If approved by the European Commission, RASONQUE would be the first broad RAS-targeted treatment option in the EU for metastatic pancreatic cancer, following its U.S.
Key figures
- Drug Name
- RASONQUE (daraxonrasib)
- Phase Of Trial
- Phase 3
- Os hazard ratio
- 0.4
- Pfs hazard ratio
- 0.49
- Median os chemo months
- 6.7
- Median pfs chemo months
- 3.6
- Risk of death reduction
- 60%
- Median os rasonque months
- 13.2
- Median pfs rasonque months
- 7.2
- Eu pancreatic cancer diagnoses annually
- 147000
AI analysis
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