Keeping Track: Kite’s Tecartus Is Third CAR-T With US FDA Approval; Submissions Round-Up
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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AstraZeneca Gets Rare Warning Letter Over Breztri Sales Aid; Footnotes Don’t Balance Graphics
Warning letter is first issued by US FDA’s Office of Prescription Drug Promotion in more than a year and only the seventh since March 2020, continuing a trend away from using the enforcement tool. AstraZeneca asked to distribute corrective communications about pamphlet’s efficacy claims.
Cell Therapy Development: White Paper Urges US FDA To Allow Some Shortcuts
A Friends of Cancer Research working group suggests that the US FDA can learn lessons from the approval of Gilead/Kite’s second CAR-T therapy Tecartus that can help expedited iterative development of cell therapies more broadly.
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.