其 他 安 全 警 示
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| European Union: No change to product information for breast cancer medicine Tyverb following re-assessment of data (English only) |
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European Medicines Agency (EMA) has announced that the product information for Tyverb, a breast cancer medicine, will continue to state that no data are available on the effectiveness of Tyverb used together with an aromatase inhibitor compared with trastuzumab used with an aromatase inhibitor in patients previously treated with trastuzumab.
In July 2018, results of a study involving women with ‘HR+/HER2+’ breast cancer and whose disease had worsened despite previous treatment with trastuzumab were added to Tyverb’s product information. The results had indicated a benefit of Tyverb over trastuzumab when each medicine was used with an aromatase inhibitor. However, in April 2019, errors were detected in the data and they were removed from the product information.
During a procedure to re-assess the data, the contract research organisation where the data were analysed was inspected. The inspection found deficiencies in the systems and procedures for managing data and concluded that data handling did not comply fully with good clinical practice (GCP). In addition, the re-analysed data do not allow a conclusion on whether Tyverb is more effective than trastuzumab when either is combined with an aromatase inhibitor.
As a result, the study results will not be re-introduced into the product information for Tyverb. There are no consequences for the current authorised uses of the medicine in the treatment of breast cancer.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/no-change-product-information-breast-cancer-medicine-tyverb-following-re-assessment-data
In Hong Kong, Tykerb Tab 250mg (HK-56194) is a registered pharmaceutical product containing lapatinib. The product is registered by Novartis Pharmaceuticals (HK) Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to lapatinib. The current package insert of the Hong Kong product states that no data are available on the efficacy of lapatinib in combination with an aromatase inhibitor relative to trastuzumab in combination with an aromatase inhibitor in this patient population.
Related news on the re-analysis of data on the use of lapatinib following treatment with trastuzumab was previously issued by the EMA, and was posted on the Drug Office website on 2 May 2019. As previously reported, the DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/ Saturday, Mar 28, 2020
Issued at HKT 14:00
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