FDA extends review on Wyeth's first-in-class mTOR inhibitor, Torisel, in advanced renal cell carcinoma

US drug major Wyeth Pharmaceuticals says that the Food and Drug Administration has extended the review of the New Drug Application for Torisel (temsirolimus), its investigational treatment for advanced renal cell carcinoma. The NDA for Torisel was originally submitted on October 5, 2006, and granted priority review status. As part of the ongoing FDA review, Wyeth recently submitted requested extra information on tumor evaluation, leading to the extension of the action date for the NDA to July 2007.

Renal cell carcinoma accounts for approximately 85% of kidney cancers, Wyeth noted. The American Cancer Society estimates that 51,190 new cases of kidney cancer will be diagnosed this year, and more than 40% of patients will be diagnosed initially with advanced disease.

The pivotal study for Torisel showed that, in patients with advanced RCC and poor prognostic features who had received no prior systemic therapy, the drug significantly increased median overall survival, the primary endpoint, 49% compared to interferon-alpha, an active comparator that has been the clinical standard-of-care.