Dear Doctor Letter (Rote-Hand-Brief) on Tyverb® (lapatinib): important update to Summary of Product Characteristics
2019.05.17
Active substance: Lapatinib
Novartis Europharm Ltd. in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that the therapeutic indication (section 4.1 lapatinib Summary of Product Characteristics) has been amended to reinstate the information that there is no data on the efficacy of lapatinib relative to trastuzumab, both used in combination with an aromatase inhibitor, in postmenopausal women with hormone receptor positive metastatic disease previously treated with trastuzumab or an aromatase inhibitor.
Corresponding information that relates to the results of Study EGF114299, has been deleted from section 5.1 of the SmPC.
For patients who are currently receiving lapatinib in combination with an aromatase inhibitor, who have previously progressed on trastuzumab containing therapy, a decision on continuation of therapy should be made on a case-by-case basis.
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