The U.S. Food and Drug Administration on Monday approved a new imaging drug that can help identify ovarian tumors during surgery.
The drug, Cytalux (pafolacianine), is meant to improve a surgeon’s ability to detect ovarian cancer while operating on a patient. It is administered intravenously before surgery and is used in conjunction with a near-infrared fluorescence imaging system approved by the FDA for use with the drug.
“The FDA’s approval of Cytalux can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected,” Alex Gorovets, M.D., deputy director of the Office of Specialty Medicine in the FDA Center for Drug Evaluation and Research, said in an agency news release. “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 FDA approval of Cytalux was based on a study of 134 women, ages 33 to 81 years. They received a dose of Cytalux and were evaluated under both normal and fluorescent light during surgery. Of those women, about 27 percent had at least one cancerous lesion detected that was not found by standard visual or touch inspection.
The most common side effects of Cytalux included nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, itching, and hypersensitivity. Also, Cytalux may cause harm to the fetus when given to a pregnant woman, the FDA warned. It also said that women should not take folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux.
The agency further cautioned there is a risk for false negatives and false positives with use of Cytalux. The drug — marketed by On Target Laboratories LLC — was previously fast-tracked for approval by the FDA.
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