Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	HER2-positive	Invasive Breast Carcinoma	Capecitabine, Lapatinib
EMA (1)	ERBB2 amplification	Invasive Breast Carcinoma	Capecitabine, Lapatinib