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In Brief: Immunex Novantrone

Executive Summary

Immunex Novantrone: Firm files supplemental NDA for use of mitoxantrone in the treatment of hormone-refractory prostate cancer, Immunex announces May 14. The company is seeking a priority review for the NDA, which includes two Phase III trials in 303 patients who previously had failed hormone treatment. In one study, serum PSA declined by 50% or more for 44% of the patients receiving Novantrone plus prednisone compared to 33% of the patients on prednisone alone. In the second study, PSA decreases of 50% or more were seen in 31% of the Novantrone patients compared to 17% of the steroid-only group. In addition, Novantrone treatment resulted in significant improvements in pain and overall quality of life. Novantrone is marketed in the U.S. as first-line therapy for acute myelogenous leukemia...

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