Imaging Drug Pafolacianine Approved by FDA for Detection of Ovarian Cancer During Surgery


Imaging drug pafolacianine was approved by the FDA to detect ovarian cancer lesions in patients during surgery.

The FDA has approved the use of pafolacianine (Cytalux), an imaging drug that can help surgeons identify lesions in patients with ovarian cancer, according to a press release from the FDA.1

Pafolacianine is designed to improve the visibility of cancerous ovarian tissue that is normally difficult to detect during surgery in adult patients. The diagnostic agent can be administered intravenously before surgery.

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

The drug was evaluated as part of a randomized, multicenter, open-label trial that featured a population of patients with ovarian cancer or who had a high clinical suspicion of ovarian cancer and were slated to receive surgery. Investigators enrolled patients between the ages of 33 and 81 years (n = 134) who were assessed under normal conditions and fluorescent light during surgery. It was reported that 26.9% of patients had at least 1 lesion detected that had not been observed through standard visual or tactile examination.

Common adverse effects associated with the drug included infusion reactions such as nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching, and hypersensitivity.

Pafolacianine previously received priority review by the FDA in March 2021 for the same patient population.2 The agent was previously examined as part of a phase 2 trial (NCT03180307), which enrolled a population of 44 patients who were diagnosed with or who had suspected ovarian cancer.3 Investigators reported an estimated sensitivity of 85.93% and a positive predictive value (PPV) of 88.14%. Additionally, when controlling for actual correlation of detection among lesions in a single patient, investigators reported a sensitivity of 97.97% and a PPV of 94.3%. Moreover, 48.3% of patients had 1 or more lesions detected through the use of pafolacianine.


  1. FDA approves new imaging drug to help identify ovarian cancer lesions. News release. FDA. November 29, 2021. Accessed November 29, 2021.
  2. On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery. News release. On Target Laboratories, Inc. March 3, 2021. Accessed November 29, 2021.
  3. Randall LM, Wenham RM, Low PS, Dowdy SC, Tanyi JL. A phase II, multicenter, open-label trial of OTL38 injection for the intra-operative imaging of folate receptor-alpha positive ovarian cancer. Gynecol Oncol. 2019;155(1):63-68. doi:10.1016/j.ygyno.2019.07.010
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