EMA Begins Safety Review of CAR T-Cell Therapies

The safety committee of the European Medicines Agency (EMA) recently started a signal procedure to review data on secondary malignancies related to T-cells, including T-cell lymphoma and leukemia, for the six chimeric antigen receptor (CAR) T-cell medicines approved in the European Union.

The data review includes the following CAR T-cell therapies:

• Axicabtagene ciloleucel (Yescarta, Kite).
• Brexucabtagene autoleucel (Tecartus, Kite).
• Ciltacabtagene autoleucel (Carvykti, Janssen Oncology and Legend Biotech).
• Idecabtagene vicleucel (Abecma, Bristol Myers Squibb). 
• Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb).
• Tisagenlecleucel (Kymriah, Novartis).

The committee is reviewing all available evidence, including information from 23 patients with T-cell lymphoma or leukemia reported to the EU’s adverse reaction database. Following the review, the EMA will decide on the need for any regulatory action.

The EMA emphasized that, for all six CAR T-cell therapies, secondary malignancies were considered as a potential risk at the time of authorization and were included in risk management plans. Additionally, the EMA stated that close monitoring is already in place, and the marketing authorization holders of the approved therapies must regularly submit interim results from ongoing long-term safety and efficacy studies.

The EMA’s data review follows news of a similar investigation by the U.S. Food and Drug Administration, which that agency announced Nov. 30.