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FDA Grants Fast-Track Development Status to CCI-779 for Renal Cell Carcinoma MADISON, NJ -- March 6, 2002 -- Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation, announced today that its investigational anticancer therapy, CCI-779, has been designated for the "fast-track" development program by the U.S. Food and Drug Administration (FDA) for the treatment of renal cell carcinoma after failure of initial therapy. The FDA's fast-track program is designed to facilitate development and expedite review of new drugs or biologicals that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. However, fast-track designation does not guarantee approval or expedited approval of any application for the product. CCI-779 is an mTOR (mammalian target of rapamycin) inhibitor. Its mechanism of action blocks the replication of certain cell types by targeting mTOR, a protein kinase central to cell growth. CCI-779 is currently in development for use in a variety of tumor types. Interleukin-2 (IL-2) is the only FDA-approved therapy used to treat renal cell carcinoma in the United States. CCI-779 received fast-track designation recognizing that patients with renal cell carcinoma who fail IL-2 therapy have a median survival of approximately six months. Renal cell carcinoma is the most common type of kidney cancer, affecting about three of 10,000 people. There are about 31,000 new cases in the United States each year, with about 12,000 deaths per year from the disorder in the United States. SOURCE: Wyeth-Ayerst Laboratories E-mail this page to a friend or colleague! To print, use this version