Wyeth has continued to make good on its claim to be entering a new product launch cycle in the coming years, with the filing of marketing applications in the USA and Europe for Torisel, a new drug to treat renal cell carcinoma.
The move comes shortly after Wyeth submitted its new schizophrenia drug bifeprunox in the USA alongside Solvay Pharmaceuticals, earlier this week, and said it expected to file for approval of seven new drugs in total in the next 18 months (check).
Torisel (temsirolimus), from a drug class known as mTOR inhibitors, is the first agent of its type to be filed for approval in a cancer indication. Phase III clinical trials have shown that Torisel increased medial survival time by 3.6 months – or around 50% - compared with interferon-alpha treatment, currently the cornerstone of renal cell carcinoma treatment.
The FDA has granted Torisel fast-track designation for first-line poor prognosis subjects with advanced renal cell carcinoma, so Wyeth could win approval in the USA as soon as next April, should the review go according to plan.
Temsirolimus has also been granted orphan drug status in both the USA and the European Union, which gives it a period of marketing exclusivity in both territories.
Renal cell carcinoma accounts for about 85% of all kidney cancers. Globally, more than 208,000 new cases of kidney cancer were diagnosed in 2002 - including about 36,700 in the U.S. and 85,700 in Europe - according to estimates from the International Agency for Research on Cancer.
If approved, Torisel will compete in the marketplace with two other recently-approved drugs for renal call carcinoma, namely Pfizer’s Sutent (sunitinib) and Bayer/Onyx’ Nexavar (sorafenib), both of which have been tipped as potential blockbusters.