The Pharmacovigilance Committee of the European Medicines Agency (EMA) has begun a review of anti-tumor therapies with CAR-T cells, personalized immunotherapies, in particular with respect to the onset of secondary malignancies, including lymphoma and T-cell leukemia.
There are six Car-T therapies approved in the EU (Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta) and 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 or is not responding to previous treatment.
The EMA explains that secondary neoplasia occurs when a patient who has one cancer (current or previous) develops a second cancer that is different from the first. And remember that for all six Car-T products currently authorized in the EU, secondary cancers were considered an important potential risk at the time of their authorization and included in the risk management plans. The Pharmacovigilance Committee is 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 drug reactions, and will decide on the need for any regulatory action.
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