Lapatinib (Tyverb) for treatment of hormone receptor positive metastatic breast cancer: important update to the therapeutic indication

Therapeutic indication has been amended to reinstate information that there is no data on efficacy of lapatinib relative to trastuzumab; both used in combination with an aromatase inhibitor in women previously treated with trastuzumab or an aromatase inhibitor.

Novartis recommends that for patients currently receiving lapatinib in combination with an aromatase inhibitor, who have previously progressed on trastuzumab containing therapy, an evaluation of benefit-risk and a decision on continuation of therapy should be made on a case-by-case basis.

These changes are due to the detection of errors in the efficacy results of Study EGF114299; the patients in this study were not previously treated with trastuzumab or an aromatase inhibitor.