Privately-held biotechnology company On Target Laboratories, Inc. announce that the U.S. Food and Drug Administration or FDA, has approved Cytalux (pafolacianine) for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.
Cytalux is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal. The drug is a diagnostic agent that is administered in the form of an intravenous injection prior to surgery. It binds to folate receptors that are overexpressed in most epithelial ovarian cancers and illuminates intraoperatively under near-infrared light.
Cytalux is used with a Near-Infrared fluorescence imaging system cleared by the FDA for specific use with pafolacianine.
Cytalux helps surgeons identify additional malignant lesions that may otherwise be missed during surgery as identifying all lesions and complete removal of all malignant tissue is the goal of ovarian cancer surgery.
Currently, surgeons rely on preoperative imaging, visual inspection of tumors under normal light or examination by touch to identify cancer lesions.
The FDA granted Cytalux priority review and both Fast Track and Orphan designations for the indication. The drug is also being investigated in cancer of the lung in a Phase 3 trial under Fast Track designation.
The approval is based on data from a randomized, multi-center, open-label Phase 3 registration trial which demonstrated that Cytalux identified additional lesions, which would have been left behind, in 27 percent of patients.
Ovarian cancer is the number one cause of gynecologic cancer death in the U.S. Cytoreductive surgery is a well-established treatment for ovarian cancer, but 40 percent of patients were found in a study to have measurable disease on 30-day postoperative imaging.
The American Cancer Society estimates there will be more than 21,000 new cases of ovarian cancer and more than 13,000 deaths from this disease in 2021, making it the deadliest of all female reproductive system cancers.
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