On Target Laboratories announces expanded indication of CYTALUX (pafolacianine) injection

Dec. 19, 2022
Injection for detection of lung cancer during surgery.

On Target Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for the use of CYTALUX in lung cancer. 

CYTALUX is a targeted molecular imaging agent that illuminates lung and ovarian cancer intraoperatively, enabling the detection of more cancer for removal. The new indication will provide surgeons the ability to integrate CYTALUX into their treatment plan for adult patients with known or suspected lung cancer, where it previously was only approved for adults with ovarian cancer.

The label expansion is based on safety and efficacy evidence demonstrated in the ELUCIDATE Trial, a Phase 3, multi-center, single dose, open-label trial that investigated the use of CYTALUX in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer. 

On Target Laboratories release