In November of 2021, the Food and Drug Administration (FDA) approved Cytalux. Cytalux is a new imaging drug intended to assist surgeons with the identification of ovarian cancer lesions1. This new drug was designed to assist in locating additional ovarian cancer tissues that can be difficult to locate during surgeries.

On average there were more than 21,000 new cases of ovarian cancer and more than half of the cases led to death. Ovarian cancer is one of the deadliest female reproductive cancers. This innovation will assist with the traditional treatment of ovarian cancer that including:

  • Surgery to remove the cancerous tumors
  • Chemotherapy to stop cell growth
  • Targeted therapy to attack cancer cells1

Cytalux was evaluated for its safety and effectiveness in an open-label and randomized study of ovarian cancer patients who were scheduled to go through surgery. 134 women received Cytalux and 26.9% of the patients had a least one additional lesion detected that was not visible under the standard methods1. Ovarian cancer tends to trigger the body to overproduce the folate receptor protein. Cytalux binds to the proteins and is illuminated under fluorescent light, assisting in the surgeon’s ability to identify any additional cancerous tissue present.

The FDA approved Cytalux to be used with a Near-Infrared imaging system to assist with the visual inspection of tumors and cancer cells during surgery. If your company needs assistance with a new drug application and/or clinical evaluation of a new drug, EMMA International is here to help. For expertise on new drug applications and clinical evaluations contact EMMA International by phone at 248-987-4497 or by email at info@emmainternational.com.

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[1] U.S. Food & Drug Administration (November 2021) FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions, Retrieved on May 31, 2022, from https://www.fda.gov/news-events/press-announcements/fda-approves-new-imaging-drug-help-identify-ovarian-cancer-lesions#:~:text=The%20U.S.%20Food%20and%20Drug,difficult%20to%20detect%20during%20surgery.

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

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