The EMA European Public Assessment Report (EPAR) for lapatinib (Tyverb) contains pharmacogenetic information regarding the indication of the drug in HER2+ (ERBB2) breast cancer, and that HER2 status should be determined using an accurate technique. It also contains pharmacogenetic information regarding an increased risk of drug-induced hepatotoxicity in patients carrying the DQA1*02:01 or DRB1*07:01 HLA alleles.
Excerpts from the lapatinib (Tyverb) EPAR:
Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2).
Lapatinib inhibits ErbB-driven tumour cell growth in vitro and in various animal models.
HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+ with gene amplification or gene amplification alone. HER2 status should be determined using accurate and validated methods.
Patients who carry the HLA alleles DQA1*02:01 and DRB1*07:01 have increased risk of Tyverb-associated hepatotoxicity. In a large, randomised clinical trial of Tyverb monotherapy (n=1,194), the cumulative frequency of severe liver injury (ALT >5 times the upper limit of normal, NCI CTCAE grade 3) at 1 year of treatment was 2.8% overall.
This information is highlighted in the following sections:
Therapeutic indications, posology and method of administration, special warnings and precautions for use, package leaflet: information for the user.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the lapatinib (Tyverb) EMA drug label.
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