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FDA grants breakthrough therapy designation to enfortumab vedotin for urothelial cancer
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The FDA granted breakthrough therapy designation to enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors, according to the manufacturers.
Enfortumab vedotin (ASG-22ME; Seattle Genetics, Astellas) is an antibody-drug conjugate composed of an anti-Nectin-4 monoclonal antibody. Nectin-4 is a cell adhesion molecule that is expressed on many solid tumors.
“The FDA breakthrough therapy designation underscores the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer,” Robert Lechleider, MD, senior vice president of clinical development at Seattle Genetics, said in a company-issued press release. “Enfortumab vedotin is at the forefront of our late-stage clinical pipeline, and we are working closely with our partner and the FDA to bring this potential new treatment to patients as quickly as possible.”
The FDA based the breakthrough therapy designation on interim results from a phase 1 study of enfortumab vedotin monotherapy for patients with metastatic urothelial cancer who were previously treated with checkpoint inhibitors.
“With the enfortumab vedotin registrational phase 2 trial and checkpoint inhibitor-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,” Steven Benner, MD, senior vice president and global therapeutic area head of oncology development at Astellas, said in the release.
The companies are also evaluating enfortumab vedotin for the treatment of other solid tumors, including ovarian cancer and non-small cell lung cancer.