EC grants orphan designation to Endocyte ovarian cancer diagnosis method On September 10, orphan designation was granted by the European Commission to Endocyte Europe for a method of diagnosis of positive folate receptor status in ovarian cancer, according to a posting made today to the European Medicines Agency website
Let's not put the cart before the horse. Diagnostic means very little if drug doesn't get approved. That said, given recent CHMP recommendation for approval of Avastin in similar, but healthier, ovarian patient population based on PFS benefit solely (#msg-79824816 ), I think it bodes well for ECYT drug's ultimate approval. Think question is more if EU will approve based on Phase 2 data or will they make MRK/ECYT wait until Phase 3 results are in hand?