引 致 更 改 给 病 人 的 产 品 资 讯 的 药 物 不 良 反 应 警 示
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| European Union: CAR T-cell medicines: PRAC identifies risk of secondary malignancies of T-cell origin (English only) |
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European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that secondary malignancies of T-cell origin (a new cancer, different from the previous one, that begins in a type of white blood cells of the immune system called T-cells) may occur after treatment with chimeric antigen receptor (CAR) T-cell medicines.
The committee evaluated data on 38 cases of secondary malignancy of T-cell origin, including T-cell lymphoma and leukaemia, reported among approximately 42,500 patients who have been treated with CAR T-cell medicines. Tissue samples were tested in half of the cases, revealing the presence of the CAR construct in 7 cases. This suggests that the CAR T-cell medicine was involved in disease development. The secondary malignancies of T-cell origin have been reported within weeks and up to several years following administration of CAR T-cell medicines. Patients treated with these medicines should be monitored life-long for new malignancies.
CAR T-cell medicines belong to a type of personalised cancer immunotherapies where one type of a patient’s white blood cells (T-cells) are reprogrammed and reinjected to attack the cancer.
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).
Since approval, the product information has advised that patients treated with these products may develop secondary malignancies. The product information and the risk management plans will be updated to include the new information concerning secondary malignancy of T-cell origin.
Healthcare professionals will be informed of the PRAC’s review conclusion on secondary malignancies of T-cell origin, including chimeric antigen receptor (CAR)-positive malignancies.
Healthcare professionals will be reminded about the need for life-long monitoring of patients for cases of secondary malignancies.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-10-13-june-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 other products mentioned in the above EMA’s announcement are not registered pharmaceutical products in Hong Kong.
The current product insert of the locally registered Kymriah product already includes safety information about secondary malignancies.
Related news was previously issued by the United States Food and Drug Administration (US FDA) and the EMA, and was posted on the Drug Office website on 29 Nov 2023, 15 Jan 2024, 24 Jan 2024 and 19 Apr 2024. Letters to inform local healthcare professionals about the risk of T-cell malignancies were issued by the DH on 24 Jan 2024. In light of the above EMA’s announcement about secondary malignancies of T-cell origin, letters to inform local healthcare professionals will also be issued.
The matters will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, June 15, 2024
Issued at HKT 13:30
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