Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized laplatinib in combination with trastuzumab for the treatment of adult patients with breast cancer, whose tumors overexpress HER2 (ErbB2), with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy in combination with chemotherapy. Lapatinib's product information sheet further defines HER2 (ErbB2) overexpressing tumors as IHC3+, or IHC2+ with gene amplification or gene amplification alone.

This is written in the approval document as:

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.

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.

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