The European Medicines Agency’s (EMA) CHMP has issued positive opinions for the conditional marketing authorizations of Vynfinit, Folcepri and Neocepri to treat adult patients with folate receptor-positive, platinum-resistant, ovarian cancer, in combination with pegylated liposomal doxorubicin (PLD).
Endocyte president and CEO Ron Ellis noted Vintafolide is a folate receptor targeted agent, and if approved, would be the first oncology therapeutic to employ an imaging agent as a companion diagnostic for patient selection.
"Today’s positive CHMP opinions are an important step toward personalizing ovarian cancer management for appropriate patients, and validate our Company’s focus on the development of targeted medicines and companion imaging agents designed to improve patient outcomes," Ellis added.
Proposed for use in combination with PLD, Vintafolide is intended to treat adult patients with platinum-resistant ovarian cancer who express the folate receptor on all target lesions. Etarfolatide and IV folic acid are proposed for diagnostic use only.
Folate receptor status should be assessed by a diagnostic medicinal product approved for the selection of adult patients for treatment with vintafolide, using single photon emission computed tomography imaging, in combination with computed tomography or magnetic resonance imaging.
Following radiolabelling with sodium pertechnetate (99mTc) solution, Etarfolatide is proposed for SPECT imaging in combination with CT or MRI, for the selection of adult patients for treatment with vintafolide. Prior to 99mTc-etarfolatide, Intravenous folic acid would be given to enhance SPECT image quality.
Applications for conditional marketing authorization for vintafolide, etarfolatide and IV folic acid have been submitted based on PRECEDENT Phase II study results in platinum-resistant ovarian cancer patients.
European Commission will review the CHMP positive opinions and if approved, the commission will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the EU, as well as European Economic Area members Iceland, Liechtenstein and Norway.