Vynfinit vintafolide regulatory update

EMA's CHMP issued a positive opinion recommending conditional approval of Vynfinit vintafolide to treat folate receptor-positive platinum-resistant ovarian cancer in combination with pegylated liposomal doxorubicin. Vynfinit is indicated for adults who express the folate receptor on all target lesions.

CHMP also backed conditional approval of companion imaging diagnostics Folcepri etarfolatide and Neocepri IV folic acid. 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 vintafolide treatment. Neocepri is indicated for administration prior to Folcepri to enhance SPECT image quality. ...