FDA Expands Cytalux Approval to Identify Lung Cancer

The FDA has approved a new indication for On Target Laboratories’ Cytalux (pafolacianine) to identify lung cancer lesions in adult patients. The drug is a diagnostic agent that is administered by intravenous injection before surgery.

The American Cancer Society estimates there will be more than 236,000 new cases of lung cancer and more than 130,000 deaths from this disease in 2022. During surgery, some lung cancer lesions can be difficult for surgeons to see, particularly if they are small, beneath the surface of the lung, or a type of lesion called a ground glass opacity, which is becoming increasingly common as the rates of lung cancer screenings rise.

Chris Barys

“Today’s approval of an expanded indication for Cytalux marks an important step forward in the treatment landscape for lung cancer and for the more than 220,000 people in the United States who receive a lung cancer diagnosis each year,” Chris Barys, president and chief executive officer of On Target Laboratories, said in a press release.

The label expansion was based on data from the phase 3 ELUCIDATE trial that investigated the use of Cytalux in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer. 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.

The most common side effects of Cytalux were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity.

Related: FDA Approves Imaging Agent to Detect Ovarian Cancer

FDA approved Cytalux in November 2021 for identifying ovarian cancer lesions.