GSK halts European application for new Tyverb indication

GlaxoSmithKline (GSK) has withdrawn its application to extend the license of its breast cancer treatment Tyverb's (lapatinib) in Europe.

The European Medicines Agency (EMA) has been notified by the pharma firm that it is no longer aiming to gain authorisation to market the drug for use in combination with paclitaxel for the treatment of patients with metastatic breast cancer whose tumours over express HER2.

The drug was initially given a conditional approval in Europe for use in combination with capecitabine for patients with advanced or metastatic breast cancer whose tumours over expressed HER2 following certain prior therapy.

Then in June, 2010, it gained an extra indication for use in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic breast cancer whose tumours overexpressed HER2.

However, GSK has had less luck proving the effectiveness of the Tyverb in the now withdrawn therapy indication.

According to the EMA, GSK said the decision was based on "the CHMP's 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The news follows latest draft guidance from the UK's National Institute for Health and Clinical Excellence (NICE) that restated its position that Tyverb did not represent value for money and should not be used on the NHS as first line treatment for metastatic breast cancer under certain conditions.

In response to NICE's latest decision, the company said further data was expected: “However, there will be an updated analysis of overall survival for this study once a higher proportion of deaths have occurred.  It cannot be predicted whether this final analysis will show a different result.”

Tyverb, which is sold in the US as Tykerb, made $231m for GSK during 2011.