FDA Black-Box Warning for Cilta-Cel Over Secondary Blood Cancers

The FDA has issued an update to the ciltacabtagene autoleucel (CARVYKTI) label describing secondary AML/MDS in 10% of patients treated on CARTITUDE-1 (10/97). CARTITUDE-1 is a Phase IB/II trial that evaluated ciltacabtagene autoleucel (CARVYKTI) in patients with relapsed of refractory multiple myeloma, and led to its FDA approval for in this setting in February 2022.

However, it is worth highlighting that the 10 patients who developed secondary malignancies were heavily pre-treated (median of 7.5 prior therapies) and some had genetic mutations prior to receiving cilta-cel. Moreover, the median time since diagnosis in the CARTITUDE-1 trial overall was 5.9 years, with 99% having been exposed to lenalidomide, and 90% prior autologous stem cell transplant (ASCT). Therefore, patients in the CARTITUDE-1 trial had other risk factors for AML/MDS, as a previous study has shown that ASCT with or without lenalidomide increases the risk of secondary malignancies.