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Breakthrough Status Arrives Late In Development Of Yervoy+Opdivo, Enfortumab Vedotin And Pedmark

 
• By Bridget Silverman

US FDA's latest BTD awards go to Seattle Genetics and Astellas' antibody-drug conjugate for immunotherapy-experienced urothelial cancer, Fennec's supportive care product to reduce cisplatin ototoxicity in pediatric cancer patients, and Bristol's double immunotherapy combo in MSI-H colorectal cancer.

The most recent recipients of FDA's breakthrough therapy designation (BTD) will see the benefits concentrated in the submission and review stages, because pivotal trials were under way before the coveted expedited review designation was granted.

While breakthrough status earns greater FDA input on development, including clinical trial design, as well as an "all-hands-on-deck" approach to review, many sponsors are deeming it worthwhile to pursue the...

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