Keeping Track: Kite’s Tecartus Is Third CAR-T With US FDA Approval; Submissions Round-Up
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Gene Therapies: US FDA Has Used Accelerated Approval Four Times Based On Intermediate Clinical Endpoints
Three of the accelerated approvals were for CAR-T products, a class that the agency considers to be gene therapies. The FDA’s September approval of bluebird bio’s Skysona for cerebral adrenoleukodystrophy was the lone non-cancer product in the group. Pink Sheet infographic tracks the required confirmatory studies and timelines for all four products.
Jazz Gets Second Indication For Xywav As First Therapy For Idiopathic Hypersomnia
Following last year’s approval in cataplexy for the Xyrem follow-on, Jazz could realize additional revenue of up to $500m annually with the first and only approval in IH, analysts say.
BMS’ Breyanzi Beats COVID-19 Constraints, Emerges As First RMAT Approval
After missing user fee date due to inspection delay, US FDA clears the CAR-T therapy for treatment of adults with relapsed or refractory large B-cell lymphoma.