Breakthrough Therapy Designations Set Quarterly Record
Executive Summary
US FDA granted designations for several products based on late-stage data; with at least 19 breakthrough therapy designations, five-year-old program sets another record in first quarter of 2018.
You may also be interested in...
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.
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.
Keeping Track: A Burst Of Breakthroughs, A Priority Review For Keytruda, And Some Supplemental Submissions
The latest drug development news and highlights from our US FDA Performance Tracker.