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Press release

November 30, 2021
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FDA approves Cytalux to identify ovarian cancer lesions during surgery

Source:

Press release

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The FDA approved the imaging drug pafolacianine to help surgeons identify ovarian cancer lesions.

Pafolacianine (Cytalux, On Target Laboratories), administered via standard IV prior to surgery, is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, which allows for detection of more cancerous tissue.

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The agent functions by binding to folate receptors, which often are overexpressed on cancer cells. It is used with a near-infrared imaging system that FDA approved specifically for use with the agent.

“Complete removal of all malignant tissue is the goal of ovarian cancer surgery, however identifying all lesions can be challenging,” Janos L. Tanyi, MD, PhD, associate professor of obstetrics and gynecology at Perelman School of Medicine at University of Pennsylvania and investigator on the phase 2 and phase 3 studies of the agent, said in a company-issued press release.

The randomized, multicenter, open-label phase 3 study included 134 women aged 33 to 81 years with ovarian cancer or high clinical suspicion of ovarian cancer who received a dose of pafolacianine prior to surgery. Results showed 26.9% of the women had one or more cancerous lesions not detected by standard visual or tactile inspection.

A subgroup analysis of 58 women with confirmed ovarian cancer who underwent interval debulking surgery showed 40% had at least one additional lesion that would have been left behind; however, the analysis was not adjusted to control for error and results should be interpreted with caution, according to the press release.

The patient-level false-positive rate of pafolacianine with the system for detection of confirmed ovarian cancer lesions was 20.2% (95% CI, 13.7-28).

The most common adverse reactions included nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity.

“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 in the FDA’s Center for Drug Evaluation and Research, said in an FDA 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.”

Pafolacianine is being studied for lung cancer in the phase 3 ELUCIDATE trial.

References:

On Target Laboratories announces FDA approval of Cytalux (pafolacianine) injection for identification of ovarian cancer during surgery. 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. Published Nov. 29, 2021. Accessed Nov. 29, 2021.
FDA approves new imaging drug to help identify ovarian cancer lesions. https://www.fda.gov/news-events/press-announcements/fda-approves-new-imaging-drug-help-identify-ovarian-cancer-lesions?utm_medium=email&utm_source=govdelivery. Published Nov. 29, 2021. Accessed Nov. 29, 2021.