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Taxol Treatment IND

Executive Summary

Approved July 17 for treatment of advanced metastatic ovarian cancer, FDA announces in a same-day "Talk Paper." The National Cancer Institute filed the Treatment IND in mid-June. Treatment protocol requires that prior to taxol therapy, patients must have failed at least two standard cancer regimens, one of which must have included a platinum-containing drug such as cisplatin. FDA says clinical studies have shown that taxol "can shrink tumors by at least one half in 20% to 30% of patients." Taxol's side effects include hair loss, neutropenia and peripheral neuropathy. The Treatment IND will be limited to designated cancer centers due to limited supplies of the drug, derived from the Pacific yew tree and manufactured by Bristol-Myers Squibb at its Mayaguez, Puerto Rico facility. FDA estimates that 1,200 ovarian cancer patients have been treated with taxol in clinicals to date. BMS is expected to supply NCI with 16 grams of taxol this year, enough to treat 8,000-10,000 patients. Bristol has said that it plans to file an NDA for taxol this summer. The NDA is likely to be reviewed under the new accelerated approval provisions.

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