BioCentury
ARTICLE | Clinical News

Neocepri IV folic acid regulatory update

March 24, 2014 7:00 AM UTC

EMA's CHMP issued a positive opinion recommending conditional approval of Neocepri IV folic acid, a companion imaging diagnostic for Endocyte's Vynfinit vintafolide, to treat folate receptor-positive platinum-resistant ovarian cancer in combination with pegylated liposomal doxorubicin. Neocepri is indicated for administration prior to Folcepri etarfolatide to enhance single photon emission computed tomography (SPECT) image quality.

CHMP also backed conditional approval of Vynfinit for adults who express the folate receptor on all target lesions; and companion imaging diagnostic Folcepri, a folate-targeted radiopharmaceutical imaging agent, for SPECT imaging in combination with CT or MRI to select patients for treatment with Vynfinit. ...