FDA approves new imaging drug to identify ovarian cancer lesions

The US Food and Drug Administration (FDA) has approved Cytalux (pafolacianine), an imaging drug intended 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.

Cytalux is indicated for use in adult patients with ovarian cancer to help identify cancerous lesions during surgery. The drug is a diagnostic agent that is administered in the form of an intravenous injection prior to surgery.

Ovarian cancer often causes the body to overproduce a specific protein called a folate receptor. Following administration via injection, Cytalux binds to these proteins and illuminates under fluorescent light, boosting surgeons’ ability to identify the cancerous tissue. Currently, surgeons rely on preoperative imaging, visual inspection of tumours under normal light or examination by touch to identify cancer lesions. Cytalux is used with a near-infrared fluorescence imaging system cleared by the FDA for specific use with pafolacianine.

The FDA’s approval follows a trial assessing the safety and effectiveness of Cytalux was evaluated in a randomised, multi-centre, 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 percent had at least one cancerous lesion detected that was not observed by standard visual or tactile inspection.

The most common side effects of Cytalux were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity. Furthermore, Cytalux may cause foetal harm when administered to a pregnant woman. The FDA also stated that there is a risk of image interpretation errors with the use of Cytalux to detect ovarian cancer during surgery, including false negatives and false positives.

“The FDA’s approval of Cytalux can help enhance the ability of surgeons to identify deadly ovarian tumours that may otherwise go undetected,” posited Dr Alex Gorovets, deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research. “By supplementing current methods of detecting ovarian cancer during surgery, Cytalux offers health care professionals an additional imaging approach for patients with ovarian cancer.”