FDA Approves Imaging Drug That Helps Surgeons Spot Ovarian Cancers

Early detection of ovarian cancer helps boost a woman’s survival, and the U.S. Food and Drug Administration on Monday approved a new imaging drug that can help spot tumors during surgery.

The drug, Cytalux (pafolacianine), is meant to improve a surgeon’s ability to detect ovarian cancer while operating on a patient.

It is administered intravenously before surgery and is used in conjunction with a near-infrared fluorescence imaging system approved by the FDA for use with the drug.

“The FDA’s approval of Cytalux can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected,” said Dr. Alex Gorovets, 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 health care professionals an additional imaging approach for patients with ovarian cancer,” Gorovets added in an agency news release.

Conventional treatment for ovarian cancer includes surgery to remove as many tumors as possible, as well as chemotherapy or other targeted therapy to identify and attack specific cancer cells.

Currently, surgeons rely on preoperative imaging, visual inspection of tumors under normal light or examination by touch to identify ovarian cancer tumors.

The FDA’s approval of Cytalux is based on a study of 134 women, aged 33 to 81. They received a dose of Cytalux and were evaluated under both normal and fluorescent light during surgery.

Of those women, about 27% had at least one cancerous lesion detected that was not found by standard visual or touch inspection.

The most common side effects of Cytalux included nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, itching and hypersensitivity. Also, Cytalux may cause harm to the fetus when given to a pregnant woman, the FDA warned.

It also said that women should not take folate, folic acid or folate-containing supplements within 48 hours before administration of Cytalux.

The agency further cautioned there is a risk of false negatives and false positives with use of Cytalux. The drug — marketed by On Target Laboratories, LLC — was previously fast-tracked for approval by the FDA.

There will be more than 21,000 new cases of ovarian cancer and more than 13,000 deaths from this disease this year in the United States, according to the American Cancer Society.

© 2021 NewsmaxHealth. All rights reserved.

There is no custom code to display.


670 KBOI GUEST BLOG: Governor Brad Little

670 KBOI GUEST BLOG: Governor Brad Little

Biden’s vaccine mandate is not the solution By Governor Brad Little Americans are deeply divided on COVID-19 and the response to it. Public health has turned political, there’s no doubt about it. But the situation playing out in hospitals across the country isn’t up for debate. There are more patients in need of critical care…

670 KBOI GUEST BLOG: Governor Brad Little

670 KBOI GUEST BLOG: Governor Brad Little

670 KBOI GUEST BLOG: Governor Brad Little Idaho to help secure U.S.-Mexico border because Biden won’t July 7, 2021 Last week I announced my plan to send Idaho State Police (ISP) troopers to Arizona to help secure the United States-Mexico border and curb the flow of illegal drugs into Idaho due to failed Biden-Harris immigration…

670 KBOI GUEST BLOG: Speaker of the House Scott Bedke

670 KBOI GUEST BLOG: Speaker of the House Scott Bedke

670 KBOI GUEST BLOG: Speaker of the House Scott Bedke   Happy Birthday, Idaho – Let’s Celebrate and Maintain the Idaho Way BY: Speaker of the House Scott Bedke, Oakley There is no better place to live, work, and raise a family than Idaho. As a proud Idaho native who believes, promotes and lives our…