GlaxoSmithKline withdraws filing seeking expanded EU approval of Tyverb

GlaxoSmithKline withdrew its EU regulatory filing seeking expanded approval of Tyverb (lapatinib) in combination with paclitaxel for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, the European Medicines Agency announced Thursday.

The agency noted that the drugmaker submitted its application in April last year, and the filing was under review by the Committee for Medicinal Products for Human Use (CHMP). The regulator indicated that the company took the decision to withdraw the submission after the CHMP said 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 drug, which is known as Tykerb in markets outside the EU, was initially authorised in Europe in 2008 for use in combination with Roche's Xeloda (capecitabine) in patients with HER2-positive advanced or metastatic breast cancer. In 2010, the product, gained expanded approval for use in combination with an aromatase inhibitor in postmenopausal women.

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