The US FDA’s concerns over early deaths associated with BCMA-targeted chimeric antigen receptor T-cell (CAR-T) therapy are being handled by labeling changes, including a new section in the Warning and Precautions section in the labeling for a new indication approved 4 April 2024 for Bristol Myers Squibb Company/2seventy Bio, Inc.’s B-cell maturation agent (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy Abecma (idecabtagene vicleucel).
Key Takeaways
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Bristol Myers Squibb/2seventy bio’s Abecma approved for triple-class exposed multiple myeloma patients after two prior lines of therapy on 4 April 2024, moving use of the CAR-T therapy earlier than its original fifth-line-plus indication.
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FDA’s inclusion of data on early deaths in the pivotal trial in the warnings and precautions section of labeling (but not the boxed warning) suggests that the agency’s concerns were assuaged by a March advisory committee meeting
“A higher proportion of patients in the Abecma arm compared to the standard regimen’s arm died within the first 9 months of randomization” in the Phase III KarMMa-3 trial, the new label notes
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