Other safety alerts
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| European Union: Start of safety review of CAR T-cell medicines |
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European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) started a signal procedure to review data on secondary malignancies related to T-cells (cancers that begin in a type of white blood cells called T-cells), including T-cell lymphoma and leukemia, for the six approved chimeric antigen receptor (CAR) T-cell medicines.
CAR T-cell based gene therapy products belong to a type of personalised cancer immunotherapies where patients' white blood cells (T-cells) are reprogrammed and reinjected to attack the cancer.
Six CAR T-cell products are approved in the European Union: 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).
A secondary malignancy is when a patient who has cancer (current or previous) develops a second cancer different from the first cancer.
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. 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.
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.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-january-2024
In Hong Kong, Kymriah (tisagenlecleucel) Dispersion For Infusion (HK-66588) is a pharmaceutical product registered by Novartis Pharmaceuticals (HK) Limited. It is a prescription-only medicine. So far, with regard to tisagenlecleucel, the Department of Health (DH) has received 18 cases of adverse drug reaction, of which 8 cases were reported as malignancies. The current product insert of the locally registered Kymriah product includes safety information on secondary malignancies – Patients treated with Kymriah may develop secondary malignancies or recurrence of their cancer. They should be monitored life-long for secondary malignancies.
The other products mentioned in the above EMA’s announcement are not registered pharmaceutical products in Hong Kong.
Related news was previously issued by the United States Food and Drug Administration, and was posted on the Drug Office website on 29 Nov 2023. As the safety review is ongoing, the DH will remain vigilant on the conclusion of the review and safety update of the drugs issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Monday, Jan 15, 2024
Issued at HKT 14:00
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