EMA Starts Safety Review of CAR T-Cell Medicines

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The European Medicines Agency (EMA) announced on Jan. 12, 2024 that its Pharmacovigilance Risk Assessment Committee (PRAC) was beginning a review of data on secondary malignancies related to T-cells for six approved chimeric antigen receptor (CAR) T-cell medicines. The committee is reviewing data from 23 cases of T-cell lymphoma or leukemia in the European Union’s EudraVigilance adverse event database.

According to EMA, secondary malignancies are those that develop when a cancer patient develops a second cancer that is different from the original cancer. This risk was considered at the time of authorization of the impacted drugs and included in risk management plans. The drugs have been monitored, and the marketing authorization holders are required to submit interim results from long-term and efficacy studies.

The impacted drugs—Breyanzi, Carvykti, Kymriah, Tecartus, and Yescarta—are approved in the EU 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 relapsed or has stopped responding to previous treatment. They are “personalized cancer immunotherapies where patients' white blood cells (T-cells) are reprogrammed and reinjected to attack the cancer.”

Source: EMA