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News Breaks
March 21, 2014
08:10 EDTECYT, MRKMerck Endocyte announce 'positive opinions' for VYNFINIT, FOLCEPRI, NEOCEPRI
Merck (MRK) and Endocyte (ECYT) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued "positive opinions" for the Conditional Marketing Authorisations of VYNFINIT and companion imaging components, imaging agent FOLCEPRI and NEOCEPRI for the treatment of adult patients with folate receptor-positive, platinum-resistant, ovarian cancer, in combination with pegylated liposomal doxorubicin. The applications for Conditional Marketing Authorization for vintafolide, etarfolatide and IV folic acid were submitted based on results in platinum-resistant ovarian cancer patients who express the folate receptor on all target lesions as evaluated in the PRECEDENT Phase 2 study. The CHMP positive opinions will be reviewed by the European Commission. If approved, the EC grants a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway. The EC usually issues a final legally binding decision within three months of a CHMP opinion.
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