The European Medicines Agency (EMA) has received formal notification from GlaxoSmithKline Research & Development of its decision to withdraw its application for an extension of the therapeutic indication for Tyverb (lapatinib) to include use in combination with paclitaxel for the treatment of patients with metastatic breast cancer whose tumours over-express HER2 (ErbB2).

In its official letter, the company stated that its decision to withdraw the application was based on the Committee for Medicinal Products for Human Use’s (CHMP) assessment that the lack of an active-controlled trial hampers the proper assessment of the benefit-risk balance in European patients in the applied indication.

The EMA press release notes that a “questions and answer” document will be made available in due course, along with a withdrawal letter from the company.

Please see link below for further details.