UF Health PROTAC cancer treatment received FDA approval for clinical trials

A drug that could treat leukemia, lymphoma and lung and breast cancers has been given approval by the Food and Drug Administration (FDA) to proceed to clinical trial. It is the first drug of its kind to receive this approval from the FDA.

DT2216 was developed by the University of Florida (UF) College of Pharmacy. It acts by breaking down proteins that causes the growth of cancer cells and makes them more resistant to therapies. It uses Proteolysis-targeting chimeras (PROTAC), small molecules that work to break down cells. This is the first PROTAC drug created in an academic lab to receive this kind of approval.


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PROTAC treats cancer through a process called protein degradation. Unwanted proteins in cells are identified and broken down by heterobifunctional molecules. A study published in 2010 by the National Institute of Health called it a “novel technology for the treatment of cancer.”

In 2019, the FDA approved a phase I clinical trial for treating patients with prostate cancer. It was the first oral PROTAC drug to make that stage of approval in the development processs.

Daohong Zhou M.D., the UF Health Cancer Center’s associate director for translation and drug development, said in a release:

“We started a great journey about six years ago to develop safer and more effective therapeutics for cancer, and we hope cancer patients can eventually benefit from our research,”

Guangrong Zheng, Ph.D., an associate professor in the UF College of Pharmacy said that the team who produced this drug is already working towards using PROTAC’s for other cancer treatments.

Per the American Cancer Society, more than 20,000 women in Florida currently have breast cancer. More than 18,000 have cancer of the lung or bronchus. They account for two of the top three most deadliest forms of cancer in Florida, with the other being prostate cancer. It is estimated that 148,000 new diagnoses of cancer have been recorded in the state since 2021 began.