Potential for Secondary Cancers Earn CAR-T Therapies FDA Boxed Warning

Less than two months after its announced investigation of secondary T-cell cancers in patients who received chimeric antigen receptor (CAR)-T cell immunotherapy cancer treatments, the FDA is mandating label updates to include a boxed warning, the agency’s most serious drug safety alert.

In letters sent Friday to manufacturers of the six approved commercial CAR-T therapies — Bristol Myers Squibb, Johnson & Johnson, Gilead/Kite Pharma and Novartis — the agency ordered revised safety information be included on packaging after it had “become aware of the risk of T-cell malignancies, with serious outcomes, including hospitalization and death, following treatment with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies.”

The products required to add a black box warning to packaging include Abecma and Breyanzi (Bristol), Carvykti (J&J), Yescarta and Tecartus (Kite) and Kymrish (Novartis), all FDA-approved separately to treat blood cancers. The named products involve all six CAR-T cell therapies approved by the FDA since 2017.

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