GlaxoSmithKline granted EU backing for new RCC treatment

GlaxoSmithKline has announced that it has been given conditional backing for its new renal cell carcinoma drug Votrient to be released in Europe.

The European Commission has granted the company a conditional marketing authorisation for the drug to be used as a first-line treatment for RCC, as well as for those patients who have previously received cytokine therapy for advanced disease.

This follows the US Food and Drug Administration’s decision to back the treatment as an advanced RCC therapy in October 2009.

As part of the conditions of the approval, GlaxoSmithKline has agreed to supply the European body with further data from ongoing clinical trials of Votrient.

This comes after the pharmaceuticals firm was last month granted approval to market its benign prostatic hyperplasia (BPH) treatment Combodart in the UK.

In the process, the treatment became the first BPH therapy approved in the UK to combine the benefits of two separate recommended monotherapies.