Cytalux Approved for Lung Cancer Lesion Detection

FDA has approved an On Target Laboratories supplemental NDA for Cytalux (pafolacianine) to help surgeons in identifying lung cancer lesions in adult patients with known or suspected lung cancer. The drug was approved 11/2021 for identifying ovarian cancer lesions.

The new indication was evaluated in a randomized, multicenter, open-label study (NCT04241315) in patients with known or suspected lung cancer who were scheduled to undergo surgery, according to an FDA release. “Of the 110 patients who received a dose of Cytalux and were evaluated under both normal and fluorescent light during surgery, 24% had at least one cancerous lesion detected that was not observed by standard visual or tactile inspection,” it says. The most common side effects of Cytalux were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity.