GSK’s Votrient approved in Europe
pharmafile | June 16, 2010 | News story | Sales and Marketing |Â Â GlaxoSmithKline, Kidney cancer, VotrientÂ
The European Commission has granted a conditional marketing authorisation for a GlaxoSmithKline drug that treats the most common form of kidney cancer.
Votrient (pazopanib) has been licensed for the first-line treatment of patients with advanced renal cell carcinoma (RCC), including those who have received prior cytokine therapy.
The disease is highly resistant to chemotheraphy and is estimated to account for 85% of all kidney cancers.
Votrient now joins the current standard first-line treatment options, Pfizer’s Sutent (sunitinib) and Bayer’s Nexavar (sorafenib), but one of the conditions of EC approval is that GSK must provide data from ongoing clinical studies.
Earlier this year the CHMP gave a conditional green light to the drug, but was waiting for comparative data on Votrient versus Sutent. The regulatory advisory committee plans to review the information it will receive by February 2011.
Votrient has already been okayed elsewhere, with the US Food and Drug Administration approving it for advanced RCC patients last October.
But GSK will need sharp elbows in the US, where Novartis’ Afinitor (everolimus) has also been approved for patients who have progressed after treatment with Sutent or Nexavar.
And Wyeth’s Torisel (temsirolimus) and Roche’s Avastin (bevacizumab) have also received the nod from the FDA.
In a phase III trial Votrient reduced the risk of tumour progression or death by 54%, regardless of prior treatment, and the overall median progression-free survival was 9.2 months with Votrient as against 4.2 months with placebo.
That figure rose to 11.1 months with treatment-naive patients compared to 2.8 months with placebo.
In common with most drugs in the RCC field, Votrient is being tested in a range of clinical trials across other tumour types.
The once-daily, oral medication is an angiogenesis inhibitor which seeks to prevent the growth of new blood vessels, a move which should in turn block the growth of kidney cancer tumours.
Adam Hill
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