Gilead defends cell therapies after inclusion on FDA warning list
Products from biotech major Gilead Sciences (Nasdaq: GILD) appear twice on a US Food and Drug Administration (FDA) list of six cell therapies that are to carry black box warnings about the risk of T-cell malignancies.
The regulator is taking this action after previously announcing that it had received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.
The FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically-modified autologous CAR-T cell immunotherapies.
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