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EMA conditional approval for Votrient

GSK's Votrient is available for first-line treatment of advanced RCC, and for patients who have previously received cytokine therapy

GSK has announced the availability of its targeted oral treatment, Votrient (pazopanib), for the first-line treatment of patients with advanced renal cell carcinoma (RCC), one of the most treatment resistant malignancies. It is also available for patients who have previously received cytokine therapy for advanced disease.

The European Medicines Agency (EMA) conditional approval was based on results from a phase III trial, which showed that Votrient reduced the risk of progression in the combined population of both treatment naïve and cytokine pre-treated patients with advanced RCC by 54 per cent compared with placebo. This equates to 9.2 months progression-free survival (PFS) with Votrient, compared with 4.2 months on placebo.

In the treatment-naïve population, PFS was significantly increased with Votrient compared to placebo. Votrient also slowed down the progression of advanced RCC in the combined population by achieving a complete or partial disappearance of the tumour (known as the overall tumour response rate) in 30 per cent of patients, compared with 3 per cent of patients on placebo. The response with Votrient was sustained for 13.5 months.

Final overall survival (OS) data are awaited, but data from an interim analysis revealed median OS of 21.1 months for Votrient-treated patients compared with 18.7 months for those on placebo.

Votrient is a selective tyrosine kinase inhibitor (TKI) that has been shown to effectively slow down the progression of advanced RCC, while maintaining quality of life (QoL). It inhibits angiogenesis (thereby slowing tumour growth and the spread of cancer to another part of the body) and may have a different tolerability profile to the other licensed TKIs.

Professor Robert Hawkins, consultant medical oncologist at The Christie, Manchester welcomes the EMA's decision. "Currently used TKIs can produce ongoing side effects such as mucositis and stomatitis, which have a profound effect on how patients are able to function day to day. Votrient provides clinicians with a welcome alternative option that may not present the same adverse event burden," Prof Hawkins said.

5th July 2010

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