Tyverb (lapatinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Novartis Europharm Limited. Tyverb (lapatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf. Revised May 2023. Accessed March 25, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
Tyverb is indicated for the treatment of adult 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. 2
Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy. 2
Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously 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. 2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) HER2-positive Invasive Breast Carcinoma Capecitabine, Lapatinib
Sensitivity (+) ERBB2 amplification Invasive Breast Carcinoma Capecitabine, Lapatinib
Sensitivity (+) ER positive, HER2-positive, PR negative Invasive Breast Carcinoma Lapatinib, Trastuzumab
Sensitivity (+) ER positive, ERBB2 amplification, PR negative Invasive Breast Carcinoma Lapatinib, Trastuzumab
Sensitivity (+) ER positive, HER2-positive, PR positive Invasive Breast Carcinoma Lapatinib, Letrozole
Sensitivity (+) ER positive, ERBB2 amplification, PR positive Invasive Breast Carcinoma Lapatinib, Letrozole