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ARTICLE | Clinical News

Bexxar tositumomab radiolabeled anti-CD20 monoclonal antibody regulatory update

March 18, 2002 8:00 AM UTC

The FDA issued a complete review letter to CRXA for its Bexxar NHL radioimmunotherapy in which the agency said additional clinical studies would be required to show evidence of safety and clinical benefit. CRXA acquired Bexxar tositumomab through its 2000 acquisition of Coulter Pharmaceutical Inc. (South San Francisco, Calif.).

CRXA said it has 10 days to amend the Bexxar application, notify the agency of its intent to amend the application, withdraw the filing or request a hearing. CRXA said it will request a meeting with the FDA, which the company expects to occur within 45 days. ...