The Pharmacovigilance Committee of the European Medicines Agency (EMA) has started a review on cancer therapies with CAR-T cells, personalised immunotherapies, with respect in particular to the occurrence of secondary malignancies, including lymphoma and T-cell leukaemia. There are six CAR-T therapies approved in the EU (Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta) and they are used to treat blood cancers such as B-cell leukaemia.
B-cell lymphoma, follicular lymphoma, multiple myeloma, and mantle cell lymphoma in patients whose cancer has come back or does not respond to previous treatment.
The EMA explains that secondary cancer occurs when a patient who has cancer (current or previous) develops a second cancer that is different from the first. And it recalls that for all six Car-T products currently authorised in the EU, secondary cancers were considered a major potential risk at the time of their authorisation and included in risk management plans. The Pharmacovigilance Committee is reviewing all available evidence, including information on 23 cases of various types of T-cell lymphoma or leukaemia in EudraVigilance, the EU database of adverse drug reactions, and will decide on the need for any regulatory action.
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