1. Pink Sheet

Kite’s Tecartus Boxed Warning Will More Closely Resemble Other CAR-Ts After FDA Changes Course

 
• By Derrick Gingery

Tecartus label still will not state that secondary malignancy cases have been reported in patients who received the product. CBER officials also address causality questions in a NEJM paper.

CAR-T cells
FDA officials said in a NEJM article that new strategies could lower the risk of secondary malignancy after CAR-T therapy. • Source: Shutterstock

Kite Pharma, Inc.’s CAR-T therapy Tecartus will remain an outlier among its peers when new safety labeling on secondary malignancy is in place, but will be much less of one after a quick change by the US Food and Drug Administration.

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