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FDA Grants Breakthrough Therapy Designation to Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer

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On March 26, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial 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).

“The FDA Breakthrough Therapy designation underscores the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer. Further, it supports our rapid development plans for this ADC, including the ongoing pivotal study in this patient population,” said Robert Lechleider, MD, Senior Vice President, Clinical Development at Seattle Genetics.

“Achieving Breakthrough Therapy designation for enfortumab vedotin is another step forward in our goal to bring an additional treatment option to patients who need it most,” said Steven Benner, MD, Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas.

The Breakthrough Therapy designation was granted based on interim results from the phase I study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with checkpoint inhibitors. Enfortumab vedotin is being studied in a pivotal clinical trial (EV-201) as monotherapy in this patient setting, and in an early-phase clinical trial in combination with checkpoint inhibitor therapy (EV-103).

About Enfortumab Vedotin

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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