FDA approves new fluorescent imaging agent capable of identifying ovarian cancer
On Target Laboratories announced that their fluorescent imaging agent, Cytalux, has received U.S. Food and Drug Administration approval, the company said Monday. The intravenous injection can be used during surgery to illuminate additional ovarian cancer lesions.
Ovarian cancer is the deadliest gynecologic cancer in the U.S. Surgery is often a standard part of treatment but even after patients undergo an operation, up to 40% may return with quantifiable disease within a month. Fluorescent imaging agents can help eliminate this risk by detecting additional malignant lesions under near-infrared light during procedures.
"Complete removal of all malignant tissue is the goal of ovarian cancer surgery, however identifying all lesions can be challenging," Janos L. Tanyi, MD, PhD, associate professor of Obstetrics and Gynecology at the University of Pennsylvania Perelman School of Medicine, said in a statement.
Cytalux works by binding to folate receptors that are often overexpressed in epithelial ovarian cancers, and can illuminate additional lesions that might have gone previously undetected.
In the phase 3 study of Cytalux, 27% of patients had additional malignancies observed during surgery, thus allowing for more complete resection.
The injection is the first of its kind to be approved for intraoperative use in ovarian cancer patients.
"We are excited about the potential impact Cytalux can have for patients in their fight against ovarian cancer. Our goal is to make Cytalux a standard of care for ovarian cancer surgery and we look forward to exploring the use of our technology for patients suffering from other cancers," said Chris Barys, president and CEO of West Lafayette, Indiana-based On Target Laboratories.
You can read the full announcement here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.