FDA Expands Approval of Cytalux to Include Lung Cancer Lesion Detection

The FDA has expanded its approval of On Target Laboratories’ injectable imaging drug Cytalux (pafolacianine), to identify lung cancer lesions in adults with known or suspected lung cancer.

Cytalux first received FDA approval in 2021 for identifying malignant lesions in adults with ovarian cancer.

In a clinical study, the imaging drug detected at least one cancerous lesion in 24 percent of participants that was not noticed through visual or tactile inspection.

The American Cancer Society estimates more than 236,000 new cases of lung cancer and more than 130,000 deaths in the U.S. in 2022, making it the deadliest form of cancer.