A New Imaging Drug to Detect Ovarian Cancer Receives FDA Approval

To help surgeons identify cancerous lesions of the female ovaries, Cytalux, an imaging drug whose active ingredient is pafolacianine, received approval on November 29, 2021, from the FDA (US Food and Drug Administration). The drug is designed to improve the ability to find additional ovarian cancer tumors that are normally difficult to detect during surgery.

Cytalux was approved for use in adult patients with ovarian cancer to help identify cancerous lesions during surgery. Administered by intravenous injection before surgery, the drug is a diagnostic agent.

FDA approval of Cytalux will help improve surgeons’ ability to identify ovarian tumors that are difficult or impossible to detect. By complementing existing methods for detecting ovarian cancer during surgery, Cytalux provides doctors with an additional imaging approach for patients with ovarian cancer.

In Turkey in 2020, 4059 women were newly diagnosed with ovarian cancer, and 2730 deaths from the disease were reported. These figures make it the cancer causing the most deaths among all female reproductive system cancers. Standard modern treatments for ovarian cancer include surgery to remove as many tumors as possible, chemotherapy to stop cancer cell growth, or other targeted drugs to identify and attack specific cancer cells.

What Is Pafolacianine’s Mechanism of Action?

Ovarian cancer cells carry excessive amounts of a specific protein on their membranes called the folate receptor. After injection, Cytalux binds to these proteins and lights up under fluorescent light, improving surgeons’ ability to identify cancerous tissue. Currently, surgeons rely on preoperative imaging, visual inspection of tumors under normal light, or examination by touch to identify cancer lesions. Cytalux is used with a near-infrared fluorescence imaging system approved by the FDA specifically for use with pafolacianine.

Cytalux’s safety and efficacy were evaluated in a randomized, multicenter, open-label study in women diagnosed with ovarian cancer or with a high clinical suspicion of ovarian cancer who were scheduled for surgery. Of the 134 women (aged 33 to 81) who received one dose of Cytalux and were assessed under both normal and fluorescent light during surgery, 26.9% had at least one cancerous lesion that was not observed by standard visual or tactile examination.

The most common side effects of Cytalux were infusion-related reactions such as nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, itching, and hypersensitivity. Cytalux may harm the fetus when given to a pregnant woman. Supplements containing folate or folic acid should be avoided within 48 hours before Cytalux administration. There is a risk of image-interpretation errors, including false negatives and false positives, when Cytalux is used to detect ovarian cancer during surgery.