The Food and Drug Administration (FDA) has approved Cytalux™ (pafolacianine), an optical imaging agent, for use in adults with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.

Cytalux is a fluorescent drug that helps identify ovarian cancer lesions during surgery. It works by binding to folate receptor (FR)-expressing cancer cells and illuminates intraoperatively under near infrared light.

The approval was based on data from a randomized open-label phase 3 study (ClinicalTrials.gov Identifier: NCT03180307) that evaluated the efficacy and safety of pafolacianine in 178 women diagnosed with ovarian cancer or with high clinical suspicion of ovarian cancer schedule to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.


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The most common adverse reactions reported with pafolacianine were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, pruritus and hypersensitivity. Pafolacianine may cause fetal harm; pregnancy testing prior to administration is recommended.

“Complete removal of all malignant tissue is the goal of ovarian cancer surgery, however identifying all lesions can be challenging,” said Janos L. Tanyi, MD, PhD, Associate Professor of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine and investigator on the phase 2 and 3 studies. “In the phase 3 study, additional cancer was detected in 27% of patients, showing great promise in the ability of Cytalux to help surgeons identify malignant lesions that may otherwise be missed during surgery.”

Cytalux is supplied as a single-dose vial containing 3.2mg/1.6mL (2mg/mL) of pafolacianine. The product is administered as a single intravenous infusion 1 hour prior to surgery and should be used with a near infrared imaging system cleared by the FDA for specific use with pafolacianine.

References

  1. FDA approves new imaging drug to help identify ovarian cancer lesions. News release. US Food and Drug Administration. Accessed November 29, 2021. https://www.prnewswire.com/news-releases/fda-approves-new-imaging-drug-to-help-identify-ovarian-cancer-lesions-301432998.html
  2. On Target Laboratories announces FDA approval of Cytalux™ (pafolacianine) injection for identification of ovarian cancer during surgery. News release. On Target Laboratories, Inc. Accessed November 29, 2021. https://www.prnewswire.com/news-releases/on-target-laboratories-announces-fda-approval-of-cytalux-pafolacianine-injection-for-identification-of-ovarian-cancer-during-surgery-301433036.html.
  3. Cytalux. Package Insert. On Target Laboratories, Inc.; 2021. Accessed November 29, 2021. https://cytalux.com/wp-content/uploads/2021/11/CYTALUX-Prescribing-Information.pdf.

This article originally appeared on MPR