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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| Canada: Summary Safety Review - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel) - Chimeric Antigen Receptor T-cell (CAR-T) Therapies - Assessing the Potential Risk of Secondary T-cell Malignancy (English only) |
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Health Canada announces that it reviewed the potential risk of secondary T-cell malignancy associated with the use of CAR-T therapies. The safety review was triggered by a labelling update in the United States for all CAR-T therapies.
Chimeric antigen receptor T-cell therapies are a type of gene therapy authorized for sale in Canada for the treatment of various blood cancers, including certain types of leukemia (cancer in the blood and bone marrow), lymphoma (cancer that forms in the immune cells of the lymphatic system) and multiple myeloma (cancer that forms in a type of white blood cell called a plasma cell) in patients whose cancer has relapsed (come back) or is refractory (has stopped responding to previous treatment). These treatments use a patient’s own T-cell to find and attack cancer cells throughout their body.
In 2024, the manufacturers of some CAR-T therapies (Yescarta, Tecartus, Carvykti and Kymriah) updated the CPM for those products to include the risk of secondary T-cell malignancy.
Health Canada reviewed the available information provided by manufacturers and foreign regulatory agencies, as well as from searches of the Canada Vigilance database and the scientific literature. Health Canada reviewed 30 cases (1 Canadian and 29 international) of secondary T-cell malignancy in patients undergoing CAR-T therapies. Of those 30 cases, 6 were found to be probably linked to the CAR-T therapies, 9 were found to be possibly linked, 9 were found unlikely to be linked and 6 (1 Canadian) could not be assessed due to missing information.
Of the probable or possible cases, the diagnosis of secondary T-cell malignancy ranged from 29 days to over 3 years following administration of CAR-T therapy. Ten deaths were reported among the 30 cases reviewed by Health Canada, with 5 occurring in cases found to be probably or possibly linked to the CAR-T therapies. However, it was not possible to determine whether the deaths were related to the CAR-T therapies due to insufficient information about the cause of death.
Patients who receive CAR-T therapies generally have advanced B-cell lymphoma or multiple myeloma and have failed other cancer therapies, including chemotherapy. Both the underlying diseases and prior therapies are important risk factors in developing T-cell malignancy. However, the role of the CAR-T therapy in the development of a secondary cancer could not be excluded.
Health Canada’s review of the available information concluded that there is a possible link between CAR-T therapies and the risk of secondary T-cell malignancy. Health Canada is working with the manufacturers to align the CPM for all CAR-T therapies to include information about the risk of secondary T-cell malignancy.
Manufacturers will be required to update their product’s educational materials to include information about this risk and a recommendation for life-long monitoring of patients for secondary T-cell malignancies. They will also be required to update testing procedures for patients with secondary T-cell malignancies, monitor data for this risk in Canada and other jurisdictions, and provide updates to Health Canada for the next 3 years.
Health Canada will inform healthcare professionals about these updates through a Health Product InfoWatch communication.
Please refer to the following website in Health Canada for details:http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1733492722458
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 Health Canada’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 European Medicines Agency (EMA), and was posted on the Drug Office website on 29 Nov 2023, 15 Jan 2024, 24 Jan 2024, 19 Apr 2024 and 15 Jun 2024. Letters to inform local healthcare professionals about the risk of secondary malignancies of T-cell origin were issued by the DH on 17 June 2024. As previously reported, the matters will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, February 1, 2025
Issued at HKT 14:00
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