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FDA approves imaging drug to help identify lung lesions during surgery

Action

The U.S. Food and Drug Administration has approved a new indication for Cytalux (pafolacianine)  to assist surgeons in identifying lung lesions in adult patients with known or suspected lung cancer. Cytalux is designed to improve the ability to locate both cancerous and non-cancerous lung lesions that may be difficult to detect during surgery. The drug is a fluorescent imaging agent that is administered in the form of an intravenous injection prior to surgery.

FDA approved Cytalux in November 2021 for identifying ovarian cancer lesions.

Disease or Condition

The American Cancer Society estimates there will be more than 236,000 new cases of lung cancer and more than 130,000 deaths from this disease in 2022, making it the deadliest of all cancers. Conventional treatment for lung cancer includes surgery to remove as many of the tumors as possible, chemotherapy to stop the growth of malignant cells or other targeted therapy to identify and attack specific cancer cells.

Effectiveness

The safety and effectiveness of Cytalux were evaluated in a randomized, multicenter, open-label study (NCT04241315) of patients with known or suspected lung cancer who were scheduled to undergo surgery. Of the 100 patients who received a dose of Cytalux and were evaluated under both normal and fluorescent light during surgery, 24% had the index surgical lesion and/or additional cancerous lesions detected that were not observed by standard visual or tactile inspection. 

Safety Information

The most common side effects of Cytalux were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, other infusion-related reactions, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort. Cytalux 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 Cytalux. There is a risk of image interpretation errors with the use of Cytalux to detect lung lesions during surgery, including false negatives and false positives.

Designations

Cytalux received priority review designation for this indication.

FDA granted this supplement approval to On Target Laboratories, LLC.

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