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FDA’s Oncologic Drugs Advisory Committee

Executive Summary

Bristol-Myers Squibb's Taxol (paclitaxel) supplemental NDA (20-262) will be reviewed by committee on Sept. 23. The supplemental NDA is for I.V. infusion of 175 mg/m Taxol over a three-hour period; Taxol is currently labeled for a 24-hour infusion of 135 mg/m. Taxol was approved Dec. 29 as a second- line therapy for refractory ovarian cancer at the lowest dose studied as per the recommendation of the advisory committee. Labeling for Taxol states that "adequate trials of dose-response have not been completed" and "larger doses...have so far produced responses similar to 135 mg/m ("The Pink Sheet" Jan. 4, p. 8). The meeting will be held at FDA's Parklawn Building, conference rooms D&E, beginning at 8 a.m.

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