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On Target Laboratories, Inc., a privately-owned biotechnology company developing fluorescent imaging agents to target and illuminate cancer during surgery, today announced that the U.S. Food and Drug Administration (FDA) has approved Cytalx is approved as an adjunct to adult patients with cancer.
Cytalux is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, allowing the detection of more cancers to be removed. Cytalax, administered by standard IV one hour before surgery, binds to folate receptors that are overexpressed in most epithelial ovarian cancers and are illuminated intermittently under near-infrared light.
Alex Gorovets, M.D., deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research, said, “The FDA’s approval of Cytalux can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected”. He further added, “By supplementing current methods of detecting ovarian cancer during surgery, Cytalux offers health care professionals an additional imaging approach for patients with ovarian cancer”.
The American Cancer Society estimates that there will be more than 21,000 new cases of ovarian cancer in 2021 and more than 13,000 deaths from the disease, making it the deadliest of all cancers of the female reproductive system. Conventional treatments for ovarian cancer include surgery to remove as much of the tumor as possible, chemotherapy to stop the growth of malignant cells, or other targeted therapies to identify and attack specific cancer cells.
Ovarian cancer often causes the body to produce a specific protein in the cell membrane called the folate receptor. After administration via injection, Cytalax binds to these proteins and illuminates under fluorescent light, increasing the ability of surgeons to identify cancerous tissue. Currently, surgeons rely on preoperative imaging, visual inspection of the tumor in normal light, or examination by touch to identify cancerous lesions. Cytalax is used in conjunction with the Near-Infrared Fluorescence Imaging System, which is approved by the FDA for specific use in conjunction with Paphosylcyanin.
The safety and effectiveness of Cytalux were evaluated in a randomized, multi-center, open-label study of women with ovarian cancer or high clinical suspicion of ovarian cancer who was to undergo surgery. Of the 134 women (aged 33 to 81 years) who received a dose of Cytalax and were assessed under both normal and fluorescent lighting during surgery, 26.9% had at least one cancerous lesion that was not present in the standard view or Touch was not observed by inspection.
The most common side effects of Cytalax were infusion-related reactions including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching, and hypersensitivity. Cytalax can cause fetal harm when given to a pregnant woman. The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours prior to administration of Cytalax. There is a risk of image interpretation errors, including false negatives and false positives, with the use of Cytolux to detect ovarian cancer during surgery.
Source: FDA
