Europe - EMA's PRAC starts safety review of CAR-T cells products related to secondary malignancies

The EMA's PRAC has announced the start of a signal procedure to review data on secondary malignancies related to T-cells, including T-cell lymphoma and leukemia, for the six approved chimeric antigen receptor (CAR) T-cell medicines.

Six CAR T-cell products are approved in the European Union (EU): Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta. These medicines are used to treat blood cancers such as B-cell leukemia, B-cell lymphoma, follicular lymphoma, multiple myeloma and mantle cell lymphoma in patients whose cancer has come back (relapsed) or has stopped responding to previous treatment (refractory).

For all six CAR T-cell products, secondary malignancies were considered as an important potential risk at the time of their authorisation and included in the Risk Management Plans (RMPs). Close monitoring is already in place and the marketing authorisation holders of the approved medicines are required to regularly submit interim results from the imposed long-term safety and efficacy studies and as part of the Periodic Safety Update Reports (PSURs).

The PRAC is now reviewing all available evidence, including information on 23 cases of various types of T-cell lymphoma or leukemia in EudraVigilance, the EU database of adverse reactions to medicines, and will decide on the need for any regulatory action.

Reference link: PRAC meeting Highlights - 8-11 January 2024