A few days after the US FDA issued letters seeking the addition of black box warnings of secondary T-cell malignancies, the agency updated its website to amend 鈥� Tecartus (brexucabtagene autoleucel) warning.
The proposed amendment for Tecartus kept the class-level boxed warning,聽similar to other CAR-T products:聽鈥淭 cell malignancies have occurred following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.”聽However, the amendment聽removed 鈥渋ncluding Tecartus鈥�, which was required for the other five CAR-T therapies.
Last week (19 January), the US FDA issued letters to all six FDA-approved CAR-T cell therapies asking that the labels for the therapies be updated to include T-cell malignancies in the black box warning section. Following the issuance of the letter, the companies have 30 days to either submit a proposal to add the black box warning proposed by the FDA or to submit a rebuttal.
The other products involved included 鈥檚 Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Gilead鈥檚 Yescarta (axicabtagene ciloleucel), 鈥� Kymriah (tisagenlecleucel), along with and 鈥檚 Carvykti (ciltacabtagene autoleucel).
There has been increased scrutiny of the risk of developing T-cell malignancies following CAR-T therapies since the FDA launched a safety probe into CAR-T cell therapies in November 2023. The FDA has released limited data on the subject, stating that 22 cases of T-cell malignancies following CAR-T therapy administration have been reported, although the agency did not specifically state a causal relationship.
A boxed warning of 鈥渟econdary haematological malignancies, including myelodysplastic syndrome and acute myeloid leukaemia鈥� was added to Carvykti in December 2023. The warning was added after 10 of the 97 patients in the CARTITUDE-1 trial developed myeloid neoplasms, which resulted in the death of nine of these patients. Legend was quick to add that the ten patients were heavily pre-treated, with some even having genetic mutations that predispose them to developing cancers.
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