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# Cytalux Approved for Lung Cancer Lesion Detection
- URL: https://www.fdaweb.com/cytalux-approved-for-lung-cancer-lesion-detection/
- Published: 2022-12-16T12:00:00.000Z
- Updated: 2026-09-14T18:10:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153420

FDA has approved an On Target Laboratories supplemental NDA for [Cytalux (pafolacianine)](https://secure-web.cisco.com/1D-8z-nfkAoETnqd6GLwzJ-RM8kfKLxQGKRsde7ElYBzQl4tn2D9O6eS0aePUp9siSUriKzNEllr6TmNTrrhsnHbnxSED2R%5FzgS5cHRnk8tXP1bifTYGqlzJLTqGS-FQnHbA5j4uvmKNdP12XuiQOlLJmYJr7tapu3d%5Fb0xxpfVrOlSMBFtWXAj0Xk1d0PsusYtHOQ0dkRCryQIY-jkFmxoXj37h3vFSCqPWbMHk%5FuHI/https%3A%2F%2Flnks.gd%2Fl%2FeyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjEyMTYuNjg0MDAxODEiLCJ1cmwiOiJodHRwczovL3d3dy5hY2Nlc3NkYXRhLmZkYS5nb3YvZHJ1Z3NhdGZkYV9kb2NzL25kYS8yMDIxLzIxNDkwN09yaWcxczAwMFRPQy5jZm0%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.-E93UwJ98-%5F5IQwWJhXcXDNjtg2U9nbQODW5CGw1zwA%2Fs%2F1255720147%2Fbr%2F150747787489-l?ref=fdaweb.com) to help surgeons in identifying lung cancer lesions in adult patients with known or suspected lung cancer. The drug was approved 11/2021 for identifying ovarian cancer lesions.

The new indication was evaluated in a randomized, multicenter, open-label study ([NCT04241315](https://clinicaltrials.gov/ct2/show/NCT04241315?term=NCT04241315&draw=2&rank=1&ref=fdaweb.com)) in patients with known or suspected lung cancer who were scheduled to undergo surgery, according to an [FDA release](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjEyMTYuNjg0MDAxODEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L2RydWdzL25ld3MtZXZlbnRzLWh1bWFuLWRydWdzL2ZkYS1hcHByb3Zlcy1pbWFnaW5nLWRydWctaGVscC1pZGVudGlmeS1sdW5nLWNhbmNlci1sZXNpb25zP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSJ9.aisUqJhwIvMSXxQne1hgXSTeZOzT6upqBushclcHZ78/s/1255931999/br/150747832026-l?ref=fdaweb.com). “Of the 110 patients who received a dose of Cytalux and were evaluated under both normal and fluorescent light during surgery, 24% had at least one cancerous lesion detected that was not observed by standard visual or tactile inspection,” it says. The most common side effects of Cytalux were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity.