Astellas Pharma Inc. and Seattle Genetics, Inc. (SGEN) announced the U.S. FDA has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate, for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors. 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 checkpoint inhibitors.
Astellas and Seattle Genetics entered into the antibody-drug conjugate collaboration in January 2007 and expanded it in November 2009. Under the collaboration, the companies are co-developing and have options to globally co-commercialize enfortumab vedotin.
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