Pafolacianine is approved for identifying malignant ovarian cancer lesions

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Jan 2022: Pafolacianine (Cytalux, On Target Laboratories, LLC), an optical imaging agent, has been licenced by the Food and Drug Administration for adult patients with ovarian cancer as an adjuvant for interoperative detection of malignant lesions. Pafolacianine is a fluorescent medication that works by targeting the folate receptor, which is overexpressed in ovarian cancer. It’s employed using a Near-Infrared (NIR) fluorescence imaging system that’s been cleared by the FDA for pafolacianine-specific use.

In a single-arm, multicenter, open-label research (NCT03180307), 178 women diagnosed with ovarian cancer or with a strong clinical suspicion of ovarian cancer who were planned to have primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery were evaluated for efficacy. Pafolacianine was given to all of the patients. In addition to standard of care evaluations such as pre-surgical imaging, intraoperative palpation, and normal light examination of lesions, 134 patients got fluorescent imaging evaluation. At least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by routine visual or tactile inspection was found in 36 (26.9%) of these individuals. In the detection of ovarian cancer lesions confirmed by central pathology, the patient-level false positive rate of pafolacianine using NIR fluorescent light was 20.2 percent (95 percent CI 13.7 percent , 28.0 percent ).

Nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, pruritus, and hypersensitivity were the most prevalent adverse effects in patients (1%).

Pafolacianine is given intravenously over 60 minutes, 1 to 9 hours before surgery, at a dose of 0.025 mg/kg. Using folate, folic acid, or folate-containing supplements within 48 hours of receiving pafolacianine is not recommended.

View full prescribing information for Cytalux

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