Updated: Gilead’s Tecartus dropped from list of CAR-Ts with updated boxed warnings
Editor’s Note: Later on Wednesday the FDA released an updated letter to Gilead that includes Tecartus in the list of CAR-T drugs that could cause secondary cancers.
Gilead’s Tecartus has been removed from the FDA’s list of CAR-T therapies that should have a boxed warning on the risks of secondary cancer after telling five other makers of the drug class to add the warning last week.
The agency wrote five safety communications dated Jan. 19 that included warnings saying explicitly that T cell malignancies “have occurred” after treatment with CAR-T therapies. The sixth stood out: The letter for Tecartus was written as these concerns “may occur.”
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