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FDA Approves Pafolacianine to Help Identify Ovarian Cancer Lesions


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On November 29, the U.S. Food and Drug Administration (FDA) approved pafolacianine (Cytalux), a targeted fluorescent imaging agent intended to assist surgeons in identifying ovarian cancer lesions. The drug, which is indicated for use in adult patients with ovarian cancer and is administered in the form of an intravenous injection prior to surgery, is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.

“The FDA’s approval of pafolacianine can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected,” said Alex Gorovets, MD, Deputy Director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research. “By supplementing current methods of detecting ovarian cancer during surgery, pafolacianine offers health-care professionals an additional imaging approach for patients with ovarian cancer.”

Conventional treatment for ovarian cancer includes surgery to remove as many tumors as possible, chemotherapy to stop the growth of malignant cells, or other targeted therapy to identify and attack specific cancer cells.

Ovarian cancer often causes the body to overproduce a specific protein in cell membranes called a folate receptor. Following administration via injection, pafolacianine binds to these proteins and illuminates under fluorescent light, boosting surgeons’ ability to identify the cancerous tissue. Currently, surgeons rely on preoperative imaging, visual inspection of tumors under normal light, or examination by touch to identify cancer lesions. Pafolacianine is used with a near-infrared fluorescence imaging system cleared by the FDA for specific use with pafolacianine.

The safety and effectiveness of pafolacianine was evaluated in a randomized, multicenter, open-label study of women diagnosed with ovarian cancer or with high clinical suspicion of ovarian cancer who were scheduled to undergo surgery. Of the 134 women (age range = 33–81 years) who received a dose of pafolacianine and were evaluated under both normal and fluorescent light during surgery, 26.9% had at least one cancerous lesion detected that was not observed by standard visual or tactile inspection. In a subgroup analysis of patients with confirmed ovarian cancer who underwent interval debulking surgery, the rate was 40% of patients (n = 58, 95% confidence interval = 0.270–0.534). However, this subgroup analysis utilized a smaller analysis set than the primary endpoint and was not adjusted to control for error, so the results may be overstated and should be interpreted cautiously.

The most common side effects associated with pafolacianine were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching, and hypersensitivity. Pafolacianine may cause fetal harm when administered to a pregnant woman. The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of pafolacianine. There is a risk of image interpretation errors with the use of pafolacianine to detect ovarian cancer during surgery, including false negatives and false positives.

The FDA previously granted Cytalux Orphan Drug, Priority, and Fast Track designations; approval was granted to On Target Laboratories, LLC.


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