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SmithKline topotecan comparability to Taxol prompts approval recommendation for ovarian cancer.

Executive Summary

SMITHKLINE HYCAMTIN COMPARABILITY TO TAXOL PROMPTS APPROVAL RECOMMENDATION for ovarian cancer by FDA's Oncologic Drugs Advisory Committee at an April 19 meeting in Bethesda, Md. The committee decided that studies 039 and 034 submitted by SmithKline Beecham for Hycamtin (topotecan) in recurrent ovarian cancer are sufficient to recommend FDA approval of the camptothecan analog. "I think that the data support that Hycamtin is at least as active as" Bristol-Myers Squibb's Taxol (paclitaxel), committee discussant Arlene Forestiere, MD, Johns Hopkins Oncology Center, said. "I think they have shown efficacy that would provide another option for treatment."
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PS028043

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