The European Medicines Agency Extends Indications for Lapatinib

Prior approval concerned combination therapy with capecitabine or an aromatase inhibitor and the EMA has now recommended lapatinib combination with trastuzumab

On 27 June 2013, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product lapatinib (Tyverb). The marketing authorisation holder for this medicinal product is Glaxo Group Ltd.

Lapatinib is indicated for the treatment of adult patients with breast cancer whose tumours overexpress HER2 (ErbB2) in combination with capecitabine or an aromatase inhibitor. The CHMP has now recommended it for the treatment in combination with trastuzumab.

The full indication for lapatinib will now be as follows:

“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;
  • in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy;
  • in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.”

Detailed conditions for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.