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FDA Grants Telcyta Fast Track Designation
"Fast Track designation is a recognition by the FDA of the serious unmet medical need faced by women with platinum refractory or resistant ovarian cancer, and the potential of TELCYTA(TM) to address that need," said Gail L. Brown, M.D., senior vice president and chief medical officer. A randomized Phase 3 registration clinical trial with TELCYTA(TM) is in progress for third line therapy in patients with platinum refractory or resistant ovarian cancer.
Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life- threatening conditions and that demonstrate the potential to address unmet medical needs.
About Ovarian Cancer and TELCYTA(TM)
Approximately 25,400 new cases of ovarian cancer will be diagnosed in 2003, according to the American Cancer Society. Ovarian cancer causes more deaths than any other cancer of the female reproductive system.
Source: Telik, Inc.