Wyeth kidney cancer drug approved in Europe
pharmafile | November 29, 2007 | News story | Sales and Marketing |
Wyeth's orphan cancer drug Torisel has been approved in Europe for difficult to treat cases of advanced renal cell carcinoma.
It offers doctors a new first-line option and a new way of treating those patients with multiple risk factors from the kidney cancer.
Torisel (temsirolimus) is the first approved cancer drug to inhibit the mTOR (mammalian target of rapamycin) kinase, an important protein that regulates cell proliferation, growth and survival.
Robert Ruffolo Jr, president of Wyeth Research, said: "The European Commission's approval of Torisel underscores the importance of this therapy for patients with advanced kidney cancer and reinforces the potential of this mechanism of action as a new approach in oncology."
Renal cell carcinoma (RCC) accounts for approximately 85% of the estimated 85,000 new cases of kidney cancer diagnosed in Europe annually.
In trials Torisel has been shown to extend median overall survival in patients with advanced RCC by 49% compared with the widely used treatment interferon-alpha.
To be prescribed Torisel patients must have three out of six risk factors, which include Karnofsky performance status of 60 or 70, lower than normal haemoglobin levels and more than one metastatic organ site.
The drug was approved for RCC in May in the US with a number of safety warnings, including that it is likely to result in hyperglycaemia and hyperlipaemia and that patients may have to start taking insulin, an oral hypoglycaemic drug or a lipid-lowering one, or even all three.
"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," said Bernard Escudier, head of immunotherapy at the Institut Gustave Roussy in France and an investigator in Torisels phase III trial.
"The ability of temsirolimus to provide an increase in overall survival in these patients provides us with a much-needed new option for the treatment of advanced kidney cancer."
Torisel will face competition from Bayer's Nexavar and Pfizer's Sutent, both of which were launched in Europe last year, becoming the first new drugs for RCC in ten years.
They could be joined by Roche's blockbuster Avastin, which is likely to be submitted to US regulators next year for approval in kidney cancer.
