Coulter Pharmaceutical's radiolabeled monoclonal antibody for thetreatment of low-grade non-Hodgkin's lymphoma, Bexxar, has achieved complete responses in seven out of 17 patients in an ongoing, 60-patient study. The other 10 patients all experienced partial responses after treatment with the antibody, although one patient who achieved a partial response has since relapsed.
This is thought to be the first time a monoclonal antibody has been used as a stand-alone therapy in newly-diagnosed cancer patients. Coulter is concentrating in the first instance in pursuing registration of the product in patients with NHL who have failed previous chemotherapy regimens, and has a Phase II/III study ongoing. The firm expects to complete enrollment into this study by year-end and hopes to file a Biological License Application in the USA in the second half of 1998.
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