Regulatory Affairs

Seattle Genetics, Astellas get FDA breakthrough therapy designation for enfortumab vedotin locally advanced or metastatic urothelial cancer

Published 27 March 2018

Seattle Genetics, and Astellas Pharma have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for enfortumab vedotin, an antibody-drug conjugate (ADC), to treat patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).

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).

Seattle Genetics clinical development senior vice president Dr Robert Lechleider said: “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.

“Seattle Genetics is an emerging multi-product oncology company, advancing a robust pipeline with the goal of improving outcomes for cancer patients.”

Astellas oncology development global therapeutic area head and senior vice president Dr Steven Benner said: “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.”

The Breakthrough Therapy Designation was granted based on interim results from the phase 1 study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with CPIs.

Enfortumab vedotin is being studied in a pivotal clinical trial, EV-201 (NCT03219333), as monotherapy in this patient setting and in an early-phase clinical trial in combination with CPI therapy, EV-103 (NCT03288545). The companies are also evaluating enfortumab vedotin in other solid tumors, including ovarian and non-small cell lung carcinoma.

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, 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.

Source: Company Press Release