Corixa to appeal Bexxar review letter

CRXA said it will submit a written request to appeal a March complete review letter for its Bexxar tositumomab radioimmunotherapy to treat non-Hodgkin's lymphoma. In that letter, the FDA said additional clinical studies would be required to show evidence of the product's clinical benefit (see BioCentury, March 18). The company's decision to request for dispute resolution follows a meeting with the agency, in which FDA reiterated to CRXA and partner GlaxoSmithKline (GSK; LSE:GSK) that the product should be tested in additional studies to assess its clinical benefit. ...