The USFDA has approved pafolacianine, a fluorescent imaging agent , to assist in the identification and localization of lung lesions in adult patients with known or suspected lung cancer during surgery. Pafolacianine has been already approved for identifying ovarian cancer lesions. Its approval for detecting lung lesions is based on data obtained in a randomized clinical trial.
Designation: Priority review Administration : The agent can be administered in the form of an intravenous injection before surgery. Clinical trial data Study design: A randomized, multicenter, open-label study Patients’ characteristics: Adults with known or suspected lung cancer who were scheduled for surgery Outcome: When recipients of a dose of pafolacianine (n=100) were evaluated under normal and fluorescent light during surgery, 24% of them were detected with the index surgical lesion and/or additional…
