Bexxar tositumomab radiolabeled anti-CD20 monoclonal antibody regulatory update

CRXA and partner GlaxoSmithKline plc (GSK; LSE:GSK, London, U.K.) received a complete review letter from the FDA requesting additional clinical and manufacturing information for Bexxar to treat relapsed or refractory, low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). Bexxar was developed by Coulter, which was acquired by CRXA last year (see BioCentury, Jan. 2). The FDA accepted the Bexxar BLA for filing in November 2000.

In its complete response letter, the FDA requested safety and efficacy data from ongoing, recently completed and other additional trials. In addition, the FDA asked for further documentation and analysis on patient diagnosis, certain adverse events, and production and manufacturing processes, plus long-term follow-up data on patient thyroid function and human anti-mouse antibody (HAMA) responses. The companies said they believe data from recently completed trials may fulfill the FDA's requests to establish safety and effectiveness and expect to provide responses to all FDA questions within three months. ...