On Target NDA for Ovarian Cancer Illuminator

FDA has accepted for priority review an On Target Laboratories NDA for pafolacianine sodium injection as an adjunct for identifying ovarian cancer during surgery. The company says that many cancers, including over 95% of ovarian cancers, over-express folate receptors to enable the uptake of folic acid. Pafolacianine sodium injection is a novel molecule which has been shown to bind to folate receptors and illuminate intraoperatively under near-infrared light, “serving as an adjunct to provide greater certainty in a complete resection,” it says. It is administered  by intravenous infusion before surgery.

The submission is based on data from clinical trials that demonstrated surgeons were able to detect additional lesions, regardless of tissue location, in 48.3% of patients. Further, pafolacianine sodium injection showed a sensitivity of 97% when controlling for detection correlation of multiple lesions within a single patient, according to the company.