FDA Approves ‘Illuminating’ Drug for Spotting Cancer

The U.S. Food and Drug Administration on Monday approved a new imaging drug, developed by a Purdue University researcher, that can help spot tumors during surgery with the use of fluorescent technology. Cytalux is marketed by West Lafayette-based On Target Laboratories Inc. and was created by Dr. Philip Low, an icon in Indiana’s life sciences sector. The FDA approved the drug for early detection of ovarian cancer, one of the leading causes of gynecological cancer deaths.

In an interview with the Associated Press, Low explained how the technology helps surgeons.

“When you turn on the fluorescent lamp, then those lesions light up like bright stars against a black sky. And it allows the surgeon to see exactly where these hidden disease tissues are located, and then they can go in and remove them,” said Low. “The surgeons were able to find additional malignant tissue or improve the practice of surgery.”

Surgeons currently rely on preoperative imaging and visual inspection of tumors. Low says that process can sometimes miss tumors, or they go undetected.

“When you think about the consequences of not finding that tissue. And you envision how simple it is to correct those deficiencies, simply by injecting a tumor targeted fluorescent dye, it’s a no brainer,” said Low.

On Target Laboratories says cytoreductive surgery is a well-established treatment for ovarian cancer. But its study shows 40% of patients had a recurrence of cancer 30-days after surgery.

“Complete removal of all malignant tissue is the goal of ovarian cancer surgery, however identifying all lesions can be challenging,” said Dr. Janos Tanyi, associate professor of obstetrics and gynecology at University of Pennsylvania and investigator on the Phase 2 and 3 studies. “In the Phase 3 study, additional cancer was detected in 27% of patients, showing great promise in the ability of CYTALUX to help surgeons identify malignant lesions that may otherwise be missed during surgery.”

Low was also the founder and chief scientific officer for West Lafayette-based pharmaceutical company Endocyte Inc. In mid-October 2018, Novartis AG. (NYSE: NVS) announced it would acquire Endocyte for $2.1 billion.