New Drug That Helps Identify Ovarian Cancer Is Approved by FDA

The Food and Drug Administration (FDA) on Monday announced the approval of a new drug that could help doctors detect ovarian cancer and improve surgical outcomes.

Pafolacianine, marketed under the brand name Cytalux, is administered as an intravenous injection just before a patient undergoes surgery to remove ovarian cancer tissue. The drug binds to a specific protein produced by ovarian cancer cells, allowing surgeons to see the cancerous tissue glowing under fluorescent light in the operating room.

Ovarian cancer treatment typically involves surgery to remove as much cancer as possible, followed by chemotherapy and other treatments intended to attack malignant cells and stop cancer from spreading. Surgeons currently rely on pre-surgerical imagining, as well as detecting cancer with the naked eye or identifying it by touch during surgery.

"The FDA's approval of Cytalux can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected," Dr. Alex Gorovets, deputy director of the Office of Specialty Medicine in the FDA's Center for Drug Evaluation and Research, said in an FDA release.

"By supplementing current methods of detecting ovarian cancer during surgery, Cytalux offers health care professionals an additional imaging approach for patients with ovarian cancer," Gorovets added.

Ovarian Cancer Drug Approval Cytalux FDA Imaging
The Food and Drug Administration announced Monday that Cytalux had been added to the arsenal of tools available to doctors identifying and treating ovarian cancer. This undated file photo depicts a patient consulting with a doctor holding a clipboard with a stethoscope placed on top. Chinnapong/Getty

A study that involved giving the drug to 134 ovarian cancer patients aged 33 to 81 found that 26.9 percent had a cancerous lesion detected that would not have been noticed using standard techniques. The most common infusion-related side effects of the drug included nausea, vomiting, abdominal pain, chest discomfort and itching.

"Complete removal of all malignant tissue is the goal of ovarian cancer surgery, however identifying all lesions can be challenging," Dr. Janos L. Tanyi, an associate professor of Obstetrics and Gynecology at the University of Pennsylvania and an investigator during Phase 2 and 3 studies of the drug, said in a statement.

"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," Tanyi stated.

Patients given Cytalux need to avoid folate, folic acid or supplements that contain folate for 48 hours before they are given the drug, as the protein that the drug binds to are folate receptors. The FDA also noted that the drug could cause harm to fetuses if administered during pregnancy.

Ovarian cancer is the most deadly form of cancer affecting the female reproductive system, according to the American Cancer Society. The organization estimates that 21,410 new cases of the disease will be diagnosed by the end of 2021—90 percent of which will be epithelial ovarian cancer, the type with the worst prognosis. Around 13,770 women are expected to die from ovarian cancer this year.