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 Gilead Sciences’ Tecartus (brexucabtagene autoleucel) warning.
The proposed amendment for Tecartus kept the class-level boxed warning, similar to other CAR-T products: “T cell malignancies have occurred following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.” However, the amendment removed “including Tecartus”, 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 Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Gilead’s Yescarta (axicabtagene ciloleucel), Novartis’ Kymriah (tisagenlecleucel), along with Johnson & Johnson and Legend Biotech’s 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 “secondary haematological malignancies, including myelodysplastic syndrome and acute myeloid leukaemia” 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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