EC refers Tyverb MAA back to CHMP

The European Commission referred an MAA for Tyverb lapatinib back to EMEA's CHMP for further discussion after receiving additional data from GlaxoSmithKline (LSE:GSK; NYSE:GSK) related to hepatotoxicity. GlaxoSmithKline is seeking EMEA approval of the HER1 and HER2 receptor kinase inhibitor in combination with capecitabine for advanced or metastatic HER2-positive breast cancer patients who have received prior therapy. The company markets the drug for the indication in the U.S. as Tykerb.

GlaxoSmithKline said it observed that hepatotoxicity may occur during treatment with Tyverb during a standard pharmacovigilance review of clinical trial and postmarketing data. It said the overall incidence of these events has been 0.4%, and that the events were generally identified through a routine blood test. The company said it has informed investigators in ongoing trials of Tyverb and healthcare providers in countries where the drug is approved to recommend increased frequency of blood tests to monitor liver function. ...