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GSK/Corixa Bexxar user fee extended

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA extends the review period for GlaxoSmithKline/Corixa's Bexxar by three months, to Aug. 1, to review additional safety data. Corixa submitted safety data in early April from an additional 375 non-Hodgkin's lymphoma patients. The data was requested by FDA after the Dec. 17 Oncologic Drugs Advisory Committee review of the tositumomab BLA. "The overall safety profile of Bexxar was not altered by the inclusion of this additional data," Corixa maintains. "A majority of the steps required for approval already have been completed," the firm notes, including satisfactory pre-approval manufacturing inspections, "agreement on several elements of post approval studies," submission of secondary draft labeling, and "completion and submission of information and procedures for drug ordering, dose preparation, dosimetry methods and dose administration." The companies remain in discussion with FDA regarding labeling and postmarketing commitment

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