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 trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy.

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)	ER positive, HER2-positive, PR negative	Invasive Breast Carcinoma	Lapatinib, Trastuzumab
EMA (1)	ER positive, ERBB2 amplification, PR negative	Invasive Breast Carcinoma	Lapatinib, Trastuzumab