The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issues a positive opinion for Conditional Marketing Authorizations for VYNFINIT (vintafolide), FOLCEPRI (etarfolatide) and NEOCEPRI (intravenous folic acid) for the treatment of adult patients with folate receptor-positive platinum-resistant ovarian cancer.
The European Commission (EC) usually issues a legally binding decision within 3 months of a CHMP opinion. EC approval grants a centralized marketing authorization that is valid in the 28 members of the EU.
If approved, this will be the first oncology therapeutic to employ an imaging agent as a companion diagnostic for patient selection.
The products were developed by Endocyte (ECYT) but will be commercialized ex-US by Merck (MRK). The partners signed a $1B collaboration deal in 2012.