Lighting Up Tumors to Improve Ovarian Cancer Surgery 

A new drug approved by the U.S. FDA may help surgeons find cancer more easily and reduce the likelihood of leaving cancer cells behind  

The U.S. Food and Drug Administration (FDA) approved the imaging drug pafolacianine (Cytalux) to aid in the identification of ovarian cancer lesions during surgery. 

Pafolacianine is a fluorescent drug that can bind to certain molecules present on ovarian cancer cells, carrying the fluorescent signal into them. Cells that have been labeled with this drug will glow when illuminated with a fluorescent lamp, while the surrounding healthy cells will remain dark. This helps surgeons detect cancer cells more easily.  

Surgery is the main treatment for most ovarian cancers. During surgery, some malignant cells can be left behind and cause disease recurrence. Therefore, highlighting cancer cells may increase the efficiency of surgery and reduce the likelihood of missing some lesions. 

The approval was based on a single-arm, multicenter, open-label clinical trial that enrolled 178 women diagnosed with or suspected to have ovarian cancer, who were scheduled to undergo surgery. All patients received a pafolacianine infusion a few hours before surgery. Among 134 patients who were evaluated by using both pafolacianine and standard of care evaluation, 26.9 percent had at least one ovarian cancer lesion detected with pafolacianine that was not observed by standard inspection through sight or touch.  

This application was granted priority review, fast track designation, and orphan drug designation. The FDA also cleared the Near-Infrared fluorescence imaging system to be used with pafolacianine. 

The FDA decision was rendered on November 29, 2021.