Wyeth submits Torisel for EU approval

Wyeth, the American pharmaceutical company, has submitted Torisel for marketing authorisation with the European Medicines Agency (EMEA).

The drug, intended to treat advanced renal cell carcinoma (RCC), has already received orphan medicinal product designation in the EU.

Wyeth has included the details of a phase III clinical trial involving 626 patients who had not received prior systemic therapy. Patients receiving Torisel demonstrated an overall mean survival time extension of 3.6 months in comparison to patients receiving interferon-alpha.

The company claims that Torisel, an mTOR kinase inhibitor, will be the first treatment for advanced RCC in its class.

Lee F Allen, vice president of oncology clinical research at Wyeth, remarked: “This is an exciting milestone, as Torisel has the potential to help many patients who have advanced RCC, if it is approved by the FDA and EMEA.”

Gary Hudes, who lead the clinical trial investigations and is director of the genitourinary malignancies programme at the Fox Chase Cancer Centre in Philadelphia, said the drug’s potential approval is “good news” since “poor-risk” patients are in constant need of new therapies to combat the disease.

According to Cancer Research UK, renal cell cancer accounts for 80 per cent of kidney cancers. The charity claims that although there are different types of renal cell cancers, they are generally treated in the same way.