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Home Industry News Wyeth kidney cancer drug gets EU approval

Wyeth kidney cancer drug gets EU approval

27th November 2007

Wyeth Pharmaceuticals has announced that Torisel (temsirolimus) has been approved by the European Commission as a first-line treatment for patients with advanced renal cell carcinoma (RCC) with three of six prognostic risk factors.

The compound has been assessed in a phase III clinical trial involving 626 patients with the condition and three or more of the preselected risk factors having not received any systemic therapy prior to the study.

In the trial, Torisel increased median overall survival by 49 per cent compared with interferon-alpha and was associated wit a significant improvement in progression-free survival.

The drug was approved for this indication in the US in May 2007.

Bernard Escudier, head of the Immunotherapy Unit in the Department of Medical Oncology at the Institut Gustave Roussy, said: “Temsirolimus was studied in the most difficult-to-treat patients with advanced renal cell carcinoma: those who have multiple risk factors that have been associated with shortened survival.”

He added that the approval of this compound provides physicians with a new therapy option for patients suffering from advanced kidney cancer.

In August 2007, Decision Resources forecast that Torisel and Roche and Genentech’s Avastin would soon challenge Sutent from Pfizer as the clinical gold standard treatment for metastatic RCC.

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