Resources for Food and Drug Administration (FDA)

Cell Therapeutics to Discuss with FDA About Filing sBLA for Zevalin

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Cell Therapeutics which markets lymphoma drug Zevalin in the U.S., said Tuesday that it has scheduled a meeting with the U.S. Food and Drug Administration, or FDA, in September. In the meeting, the biotechnology company will talk about the possibility of filing a supplemental Biologics License Application, or sBLA, for using Zevalin as a consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma, or NHL.

The Seattle, Washington-based company noted that the basis for the filing would be data taken from the First-line Indolent Trial of Bayer Schering Pharma (BSGP.L). Cell Therapeutics recently gained access to the study results through an agreement with Bayer Schering.

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