Folcepri etarfolatide regulatory update
Merck withdrew an MAA from EMA seeking conditional approval of Folcepri etarfolatide, a companion imaging diagnostic for Endocyte's Vynfinit vintafolide, to treat folate receptor-positive platinum-resistant ovarian cancer in combination with pegylated liposomal doxorubicin. The companies made the decision based on further review of interim data from the Phase III PROCEED trial, which was suspended earlier this month after an independent DSMB recommended stopping the trial early for futility. The trial was evaluating Vynfinit in combination with doxorubicin to treat folate receptor-positive platinum-resistant ovarian cancer (see BioCentury, May 5). The companies terminated the trial and are reviewing the data to determine next steps for vintafolide in platinum-resistant ovarian cancer.
The partners also withdrew MAAs seeking conditional approval of Vynfinit and Neocepri IV folic acid, a companion imaging diagnostic for Vynfinit. EMA's CHMP had issued positive opinions in March recommending conditional approval for Vynfinit, Neocepri and Folcepri (see BioCentury, March 24). ...