The Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate (ADC) for patients with locally advanced or metastatic urothelial cancer who have been treated with checkpoint inhibitors (CPI). 

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to monomethyl auristatin E, a microtubule-disrupting agent. Enfortumab vedotin targets Nectin-4, which is expressed on many solid tumors, particularly bladder cancers.

The Breakthrough designation was based on interim results from a Phase 1 study which examined enfortumab vedotin as monotherapy in patients with metastatic urothelial cancer who were previously treated with CPIs. The Companies are currently recruiting patients for 2 separate Phase 2 trials for this treatment, one as a monotherapy (EV-201) and one in combination with CPI therapy (EV-103). 

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“With the enfortumab vedotin registrational Phase 2 trial and CPI-combination trial actively underway, Astellas looks forward to expanding development of enfortumab vedotin and its oncology pipeline, including treatments that would target some of the hardest-to-treat cancers,” said Steven Benner, MD, SVP of Oncology Development at Astellas. 

Enfortumab vedotin is being developed by Astellas Pharma and Seattle Genetics. In addition to urothelial cancer, the Companies are also evaluating enfortumab vedotin in ovarian and non-small cell lung carcinoma.

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