Folcepri etarfolatide regulatory update
EMA's CHMP issued a positive opinion recommending 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. Folcepri, a folate-targeted radiopharmaceutical imaging agent, is indicated for single photon emission computed tomography (SPECT) imaging in combination with CT or MRI to select patients for treatment with Vynfinit.
CHMP also backed conditional approval of Vynfinit for adults who express the folate receptor on all target lesions; and companion imaging diagnostic Neocepri IV folic acid for administration prior to Folcepri to enhance SPECT image quality. ...