Medical Technology

FDA approves Ovarian Cancer Lesions Imaging Drug

The US Food and Drug Administration has approved pafolacianine (Cytalux) as an imaging drug approved for use in adult patients suffering from ovarian cancer who are undergoing surgery.

The new drug “is created to enhance the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery,” according to the agency.

Pafolacianine, administered via intravenous injection prior to surgery, is the first FDA-approved tumor-targeted fluorescent agent for ovarian cancer.

Philip Low, a drug inventor from Purdue University in West Lafayette (Indiana) said that the agent causes the ovarian tumors to “light up like star against a night sky.”

It is vital to improve the detection of ovarian cancer lesions since this is the most deadly of all female reproductive system cancers. According to the American Cancer Society, it is also the most dangerous. According to the American Cancer Society, there will be more than 21,000 new cases and more than 13,000 deaths by 2021.

Currently, surgeons employ preoperative imaging as well as examination of tumors with normal lighting and examination with touch to identify ovarian cancer lesions.

Pafolacianine is a brand new tool that will enhance surgeons’ ability “to identify dangerous ovarian tumors that might otherwise be missed,” Alex Gorovets, MD, director-in-charge of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research in a statement to the press.

The body can increase the production of folate receptor proteins in cell membranes as a result of the ovarian cancer. Pafolacianine is a drug that is used in conjunction in conjunction with a near-infrared-fluorescence imaging system that has been approved by the FDA for use alongside the drug, binds to and illuminates these proteins with fluorescent light, “boosting surgeons’ ability to detect cancerous tissue,” the agency in an announcement.

A multicenter, randomized open-label study, with a multi-center design, was conducted to assess the safety and efficacy of pafolacianine for women suffering from cancer of the ovary. 26.9% of the 134 women who underwent surgery had at least one lesion that could be considered cancerous. They were evaluated under fluorescent and normal light.

Infusion-related reactions were among the most frequent side effects of pafolacianine. These included nausea flushing, vomiting abdominal pain and flushing, along with itching, itching and chest discomfort.

Pafolacianine can cause fetal harm when given to pregnant women. Before pafolacianine is administered, pregnant women should not take folate, or folic acid.

FDA also warned of the potential for mistakes in interpretation of images, such as false negatives or false positives with the new drug and near infrared fluorescence imaging systems.

The FDA has previously granted pafolacianine priority, priority and fast track designations to pafolacianine.

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