Other safety alerts
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| European Union: Pemazyre (pemigatinib) - opinion on variation to marketing authorization |
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The European Medicines Agency (EMA) has recommended the refusal of a change to the marketing authorisation for Pemazyre to extend its use to the treatment of myeloid/lymphoid neoplasms with fibroblast growth factor receptor 1 (FGFR1) rearrangement (changes in the FGFR1 gene that produce an abnormal form of a protein called FGFR1). Myeloid/lymphoid neoplasms are very rare cancers that affect the bone marrow and white blood cells.
The active substance in Pemazyre, pemigatinib, belongs to a group of medicines called protein kinase inhibitors. It works by blocking the activity of tyrosine kinase receptors, such as FGFR receptors. Abnormal FGFR receptors are found on the surface of cancer cells and are involved in the growth and spread of the cancer. By blocking their activity, Pemazyre slows the progression of the cancer.
EMA considered that the data were not sufficiently comprehensive, meaning that there were remaining uncertainties about the benefits and risks of the medicine. The study did not compare Pemazyre with another treatment or placebo and included a small number of patients, reflecting a limited range of the different forms of the disease. This, in addition to changes that were made in the design of study while it was carried out could have affected the validity of the results.
The company was requested to generate additional data after authorisation on the benefits and risks of Pemazyre in myeloid/lymphoid neoplasms with FGFR1 rearrangement to address the remaining uncertainties.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/medicines/../pemazyre
In Hong Kong, Pemazyre Tablets 13.5mg (HK-67328), Pemazyre Tablets 4.5mg (HK-67329) and Pemazyre Tablets 9mg (HK-67330) are pharmaceutical products registered by Innovent Biologics (HK) Limited. All are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to pemigatinib. The indication of Pemazyre approved in Hong Kong included locally advanced or metastatic cholangiocarcinoma but not the myeloid/lymphoid neoplasms. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/ Saturday, March 29, 2025
Issued at HKT 12:45
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