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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