IDEC's Rituximab Filed In USA & Europe

IDEC Pharmaceuticals and Genentech have submitted a Biological LicenseApplication to the US Food and Drug Administration for IDEC-C2B8 (rituximab), a single-agent therapy for the treatment of relapsed low-grade or follicular non-Hodgkin's lymphoma. Licensee Hoffmann-La Roche has also submitted a Marketing Authorization Application for the drug to the European Medicines Evaluation Agency.

If approved, this would be the first monoclonal antibody for the treatment of cancer to be made available on the US market, and would also represent the first marketed product for IDEC. The filings come only two years after the IDEC/ Genentech collaboration was initiated, say the companies.

Half Of Patients Experienced Tumor Reduction The dossier contains data from Phase III trials with the drug, which were presented at the American Society of Hematology meeting in December last year. When the drug was administered as a monotherapy, half of the 151 evaluable patients experienced tumor shrinkage of 50% or greater, and 70% of these patients were still in remission at nine months follow-up.