WYETH FILES IN U.S., EUROPE FOR RCC TREATMENT

Wyeth Pharmaceuticals announced it has initiated its global filing strategy for Torisel (temsirolimus) with the simultaneous submissions of a new drug application (NDA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMEA). The company is seeking an indication for the treatment of patients with advanced renal-cell carcinoma (RCC).

The applications contain interim data from a three-arm, Phase III trial of 626 patients who had received no prior systemic therapy. The primary endpoint of the study was overall survival. The results showed treatment with Torisel increased median overall survival time by 3.6 months, or 49 percent, compared with treatment with interferon-alpha. The final analysis will also be submitted to regulatory authorities at a future date.

Torisel is an investigational drug that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a protein that regulates cell proliferation, cell growth and cell survival. If approved, Torisel would be the first agent in this class indicated for the treatment of a cancer.

The FDA in 2004 granted fast-track designation for Torisel for poor-prognosis subjects with advanced RCC and granted orphan drug designation to investigational temsirolimus for the treatment of RCC. In 2006 Torisel received orphan medicinal product designation for the treatment of RCC in the European Union.