Right on cue, Seattle Genetics Inc. and Astellas Pharma Inc. have announced positive top-line results from a pivotal Phase II study of the antibody-drug conjugate (ADC), enfortumab vedotin, in locally advanced or metastatic urothelial cancer, and the partners are on track to submit a US BLA for the antibody-drug conjugate, under the FDA’s accelerated approval pathway, later this year.
In the single-arm trial conducted by Astellas and Seattle Genetics, known as EV-201, there was a 44% objective response rate...



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