FDA approves new drug for identification of ovarian cancer

pharmafile | November 30, 2021 | News story | Manufacturing and Production  

The FDA announced the approval of pafolacianine, marketed as Cytalux, a new drug which could help doctors detect ovarian cancer and improve surgical outcomes. The new imaging drug can help doctors spot tumors during surgery and was invented at Purdue University. Pafolacianine is administered intravenously before surgery, and used in conjunction with a near-infrared fluorescence imaging system approved by the FDA for use with the drug. Early detection of ovarian cancer boosts patient survival.

Pafolacianine is a fluorescent imaging agent that binds to a specific protein produced by ovarian cancer cells, illuminating cancerous lesions and tumours, and allowing surgeons to see the cancerous tissue.

Ovarian cancer treatment usually involves surgery to remove as much cancerous tissue as possible. The surgery is then followed by chemotherapy and other treatments, intended to attack malignant cells and stop cancer from spreading. This process currently relies on preoperative imaging, as well as detecting cancer through visual inspection of tumours under normal light, or examination by touch during surgery. The approval of pafolacianine may prove significant in removing the margin for human error.

In a Phase III clinical trial, surgeons were able to find additional tumours in 27% of the patients which would have otherwise been left behind. The study looked at 134 women, aged 33 to 81, who received a dose of Cytalux and were evaluated under both normal light and fluorescent light during surgery. The drug should not be taken by pregnant patients.

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

Cytalux, or pafolacianine, is the first tumour-targeted fluorescent agent for ovarian cancer to be approved by the FDA.

Ana Ovey

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