CYTALUX and Its Benefits to Patients With Ovarian Cancer

In 2022, the American Cancer Society predicts that approximately 19,880 women will receive a new diagnosis of ovarian cancer. And around 12,810 women will die from the disease.

For ovarian cancer, treatment usually involves a combination of surgery and chemotherapy. According to Cancer Research U.K., 64 percent of ovarian cancer patients will have surgery as part of their primary cancer treatment. The goal of surgery is to remove malignant tissue.

However, it can be challenging to detect all the cancer cells and lesions during an operation. CYTALUX is the first targeted fluorescent imaging agent approved by the U.S. Food and Drug Administration (FDA) to help address this problem.

What is CYTALUX?

Leslie Randall, M.D., a professor of Gynecologic Oncology, Department of Obstetrics and Gynecology, at VCU Health in Richmond, Virginia, tested CYTALUX during the clinical trials.

"CYTALUX is almost like a contrast, similar to when you have a computerized tomography (CT) scan, and you get given contrast intravenously—but it's more specific to tumors," Randall explained.

The fluorescent dye CYTALUX is administered intravenously to a patient before surgery. It binds to ovarian cancer cells, allowing surgeons to determine tumor margins and find additional tumors.

How does CYTALUX work?

At present, surgeons rely on imaging, the naked eye, and touch to identify cancer lesions for removal. Often they have to remove large margins around malignant tissue, which can mean taking away a lot of healthy tissue.

Randall explained that CYTALUX targets folate (a type of B vitamin)—and folate receptors are overproduced on ovarian cancer cells. The drug has a fluorescent marker that binds to these receptors. Once attached to the folate receptor, surgeons can see the marker under fluorescent light, helping them identify cancerous tissue.

"It can sometimes be difficult to identify all the malignant lesions that need removing," Randall said. "If you can't see or feel it, you can't remove it. CYTALUX helps accomplish the goal of removing cancerous tissue while preserving as much healthy tissue as possible."

Randall also said that chemotherapy is often prescribed before surgery. If a patient has had chemotherapy, she says, it can be challenging to determine what part of the tumor is still active and what has been killed by the chemotherapy.

"If chemotherapy was effective in killing part of a tumor, that part does not need to be removed during surgery," Randall stated. CYTALUX can help identify whether tissue areas are still actively cancerous or not. "That's a very positive thing," she continued, "as you can confidently do less surgery and know that you are still removing the cancerous tissue."

Is CYTALUX suitable for all ovarian cancer patients?

Randall advises that CYTALUX is available specifically to women with epithelial ovarian cancers who are planning for surgery. "It's not suitable for women who are not having surgery or who have germ cell types, or non-epithelial types, of ovarian tumor," Randall specified.

CYTALUX is a one-time dose administered right before surgery and clears the system soon after the operation. However, Randall advises that there can be side effects that are primarily local infusion reactions, such as hives or nausea. They tend to be relatively short-lived and predominantly mild. She stated that no significant side effects were seen in the clinical trials.

One point to note is that CYTALUX is currently available only in highly specialized cancer centers.

Why is this such a significant breakthrough in cancer treatment?

"The FDA's approval of CYTALUX can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected," said Alex Gorovets, M.D., deputy director of the Office of Specialty Medicine in the FDA's Center for Drug Evaluation and Research. "By supplementing current methods of detecting ovarian cancer during surgery, CYTALUX offers healthcare professionals an additional imaging approach for patients with ovarian cancer."

CYTALUX is the first fluorescent imaging agent of its kind to target and illuminate cancer during surgery. "We've never had an agent that targets and binds to the cancer cells directly—no matter where they are," Randall said. "If we are going to do surgery, we can now do the best and least invasive surgery that we possibly can."