An overview of Tyverb and why it is authorised in the EU
Tyverb is a cancer medicine used to treat patients with breast cancer that has been shown to be ‘expressing’ large amounts of HER2. This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the cancer cells. Tyverb is used in the following ways:
- in combination with capecitabine (another cancer medicine) when the cancer is advanced or metastatic and got worse following previous treatment including an anthracycline and a taxane (other types of cancer medicine), and following treatment of the patient’s metastatic disease with trastuzumab (another cancer medicine). ‘Advanced’ means that the cancer has started to spread and ‘metastatic’ means that the cancer has already spread to other parts of the body;
- in combination with trastuzumab for metastatic cancer that does not respond to hormones (hormone receptor-negative disease), and which got worse when previously treated with a combination of trastuzumab and other cancer medicines (chemotherapy);
- in combination with an aromatase inhibitor (another type of cancer medicine) in women who have been through the menopause, when the cancer is metastatic and responds to hormones. This combination is used in women who do not currently need to receive standard chemotherapy to treat their cancer.
Tyverb contains the active substance lapatinib.
Tyverb : EPAR - Medicine overview (PDF/90.66 KB)
First published: 26/06/2008
Last updated: 07/09/2018
Tyverb : EPAR - Risk-management-plan summary (PDF/142.18 KB)
First published: 07/09/2018
Last updated: 07/09/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
13/12/2018 Tyverb - EMEA/H/C/000795 - II/0057
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2):
- in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting;
- in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy;
- in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.