Breakthrough Status Arrives Late In Development Of Yervoy+Opdivo, Enfortumab Vedotin And Pedmark
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.
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Priority Reviews At US FDA: From Third Quarter Spikes To A Third Quarter Trough
Priority review announcements saw significant dip in third quarter 2018, while they usually experience a spike during the period; breakthrough therapy designations remained in double digits.