Reason for request

Extension of indication


Clinical Benefit


the actual benefit of TYVERB is moderate in 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.”

Clinical Added Value

no clinical added value

Taking into account the lack of data showing a benefit versus a clinically relevant comparator, the methodological limitations of the study based primarily on a post-hoc analysis, and the lack of benefit in terms of progression-free survival in the subgroup of HER2+ and HR- patients, the Committee considers that TYVERB, in combination with trastuzumab, does not provide any improvement in actual benefit (level V, non-existent) in comparison with the usual management of breast cancer with HER2 (ErbB2) overexpression in patients with hormone receptor-negative metastatic disease.

Therapeutic use


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