The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for pafolacianine sodium injection (On Target Laboratories, Inc) as an adjunct for identifying ovarian cancer during surgery.
Pafolacianine sodium is administered via intravenous infusion prior to surgery. It binds to folate receptors commonly found on many cancers, including ovarian and lung cancers, and illuminates the cancerous lesions under near-infrared light. This allows surgeons to identify more malignant tissue that may have otherwise gone undetected.
The NDA submission is supported by data from a phase 2 (ClinicalTrials.gov: NCT02317705) and a phase 3 (ClinicalTrials.gov: NCT03180307) trial that evaluated the efficacy and safety of pafolacianine sodium injection in patients with folate receptor-positive ovarian cancer scheduled to undergo surgery. Results from the phase 2 trial showed that surgeons were able to detect additional lesions, regardless of tissue location, in 48.3% of patients. Additionally, sensitivity was estimated to be 97% when controlling for detection correlation of multiple lesions within a single patient.
The Company is also investigating pafolacianine sodium injection in the phase 3 ELUCIDATE trial (ClinicalTrials.gov: NCT04241315) for the intraoperative detection of lung cancer lesions.
On Target Laboratories announces U.S. FDA acceptance and Priority Review of New Drug Application for pafolacianine sodium injection for identification of ovarian cancer during surgery. [press release]. West Lafayette, IN: On Target Laboratories, Inc.; March 3, 2021.