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FDA approves drug that 'lights up' lung cancer cells during surgery

Purdue University's Philip Low is an inventor of the fluorescent imaging agent Cytalux, whose use was expanded by the Food and Drug Administration to help surgeons find lung cancer cells. The drug was first approved in November 2021 to help detect ovarian cancer. Photo by Rebecca McElhoe/Purdue University
Purdue University's Philip Low is an inventor of the fluorescent imaging agent Cytalux, whose use was expanded by the Food and Drug Administration to help surgeons find lung cancer cells. The drug was first approved in November 2021 to help detect ovarian cancer. Photo by Rebecca McElhoe/Purdue University

Dec. 19 (UPI) -- To help surgeons with the exacting task of finding and removing lung cancer cells, and sparing healthy tissue, the Food and Drug Administration has approved a fluorescent imaging agent that "lights up" lung cancer cells for easier detection.

The prescription medication, Cytalux, or pafolacianine, was first approved by the FDA in November 2021 to help detect ovarian cancer during surgery. It received permission for the additional use on Friday.

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Now, researchers cite its potential to improve the outcomes of thousands of lung cancer patients.

Cytalux, which is given as an intravenous injection to adults prior to surgery, is designed to improve the ability to locate cancerous lung tissue that is normally difficult to detect during surgery, the FDA said.

In a study of safety and effectiveness, of the 110 non-small cell lung cancer patients who received a dose of Cytalux and were evaluated under both normal light and fluorescent light during surgery.

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The FDA said 24% had at least one cancerous lesion detected that was not observed by standard visual inspection or by touch.

Cytalux received priority review designation for this new indication, the FDA noted.

The FDA pointed to the American Cancer Society's national estimates that 236,000-plus new cases of lung cancer and more than 130,000 deaths from it would be recorded in 2022, "making it the deadliest of all cancers."

Cytalux was developed by On Target Laboratories, a privately held biotechnology company based in West Lafayette, Ind., also home to Purdue University.

The technology is based on the work of Philip S. Low, Purdue's Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry in the College of Science.

Low is the founder and chief science officer of On Target Laboratories.

"Non-small cell lung cancer is one of the deadliest cancers. The only absolute cure for lung cancer is to surgically remove all of the malignant tissue out of the patient. If it has metastasized, it's generally lethal," Low said in a news release.

He added: "We were not only the first tumor-targeted fluorescent dye to be approved by the FDA, but we developed a second one close on its heels. We are also working on other tumor-targeted fluorescent dyes to target many other types of cancer."

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While it is important to remove all malignant tissue, it is difficulty to distinguish cancerous tissue from healthy tissue in this type of non-small cell lung cancer, and it is widespread in nature, Low said.

According to Low, Cytalux "exploits the unique chemistry of cancer cells" to light up tumors. Cancer cells divide rapidly, much faster than normal cells, and to do this, they need a significant amount of folate, a type of B vitamin.

After being administered intravenously to a patient before surgery, Cytalux tags the folate compound with a fluorescent dye -- so cancer cells grab for the folate, but end up also being flagged with the dye. During surgery, these cells light up under near-infrared light.

Low explained how the drug works in a YouTube video when Cytalux first was approved by the FDA a year ago.

According to Low, the drug not only allows the surgeon to see the cancer, but also may help surgeons avoid removing healthy tissue.

On Target Laboratories notes there may be adverse reactions to Cytalux, including nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort and allergic reactions.

And the biotech firm points out potential issues with its use.

"Errors may occur with the use of Cytalux. Sometimes cells may light up even if they are not cancerous or those that are cancerous may not light up. Also, non-cancerous cells from other areas may light up, such as areas of the bowel, kidneys, lymph nodes, lungs, and inflamed tissue," the company said on its website.

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The biotech said, too, that folic acid may reduce the detection of cancerous tissue with Cytalux. So, patients should stop taking folate, folic acid, or folate-containing supplements 48 hours before receiving the drug.

Low said he and his team continue to develop imaging agents to make cancer tumors easier to detect and remove.

Low conducts his research as part of the Purdue Center for Cancer Research, one of seven basic science laboratory cancer centers recognized by the National Cancer Institute, which is part of the National Institutes of Health.

Purdue said more than 110 researchers study cancer at the cellular level at its center.

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