Breakthrough Therapy Designation Awarded for Enfortumab Vedotin
by Dr. C.H. Weaver M.D. (07/2018)
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to enfortumab vedotin for patients with locally advanced or metastatic urothelial (bladder) cancer who were previously treated with checkpoint inhibitors.
Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. It is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
About Enfortumab Vedotin
Enfortumab vedotin is a novel precision cancer medicine known as an antibody drug conjugate. It is composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target which is expressed on many solid tumors.
The Breakthrough Therapy Designation was granted based on interim results from the phase 1 clinical study examining enfortumab vedotin as treatment for patients with metastatic urothelial cancer who were previously treated with checkpoint inhibitors. Clinical trials are ongoing to further evaluate enfortumab vedotin in individuals with advanced bladder cancer.
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