Summary

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• Cytalux (pafolacianine) is indicated as an adjunct for intraoperative identification of malignant lesions in adult patients with ovarian cancer, and for intraoperative identification of malignant and non-malignant pulmonary lesions in adult patients with known or suspected lung cancer.
• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• Lung Cancer: Clinically significant events were observed in 53% of participants, surpassing the prespecified threshold of 10% (P < .0001). Pafolacianine identified margins 10 mm or less from the resected nodule in 38% of participants, and intraoperative molecular imaging detected primary nodules not visible by white light and palpation in 19% of cases.
• Ovarian Cancer: Pafolacianine identified additional cancer in 33% of patients, exceeding the prespecified threshold of 10% (P < .001). Sensitivity for detecting ovarian cancer was 83%, with a 24.8% false-positive rate, and a complete R0 resection was achieved in 62.4% of patients.
• Lung Cancer: No drug-related serious adverse events occurred; studies suggest a favorable safety profile but do not specify non-serious adverse events.
• Ovarian Cancer: Drug-related adverse events occurred in 30% of patients, primarily nausea, vomiting, and abdominal pain; no drug-related serious adverse events or deaths were reported.
• There is no population type or subgroup information available in the reviewed studies.