GlaxoSmithKline gets conditional EU approval for Votrient; Genmab's Arzerra backed by CHMP; EMEA updates on J&J's Velcade label
In a furry of news from European regulators, UK drugs giant GlaxoSmithKline confirmed that the European Commission has granted a conditional marketing authorization for Votrient (pazopanib) for the first-line treatment of advanced Renal Cell Carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.
As part of these conditions, GSK said it will provide data from ongoing clinical studies, including a comparison with Pfizer's Sutent (sunitinib).
The decision follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in (The Pharma Letter February 22). The US Food and Drug Administration approved the use of Votrient as a treatment for patients with advanced RCC last fall (TPL October 6, 2009.
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