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# Imaging Drug OK’d for Ovarian Cancer Detection
- URL: https://www.fdaweb.com/imaging-drug-okd-for-ovarian-cancer-detection/
- Published: 2021-11-29T12:00:00.000Z
- Updated: 2026-09-14T17:23:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150657

FDA has approved an On Target Laboratories NDA for Cytalux (pafolacianine), an imaging drug to assist surgeons in identifying ovarian cancer lesions. “The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery,” FDA says in a [news release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-imaging-drug-help-identify-ovarian-cancer-lesions?ref=fdaweb.com).  
  
The agency says that ovarian cancer often causes the body to overproduce a specific protein in cell membranes called a folate receptor. Injectable Cytalux works by binding to the proteins and illuminating them under fluorescent light, boosting surgeons' ability to identify the cancerous tissue. “Cytalux is used with a Near-Infrared fluorescence imaging system cleared by the FDA for specific use with pafolacianine,” it says.

Approval was based on data from an 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 (ages 33 to 81 years) who received a dose of Cytalux 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,” the agency says.