Immunex Novantrone
Executive Summary
Supplemental NDA filed June 3 for secondary progressive multiple sclerosis indication. Immunex is requesting a priority review. Novantrone (mitoxantrone) reduced by 21% the relapse rate and disability progression in 194 patients with secondary progressive multiple sclerosis, according to results of a two-year pivotal trial. Third-year follow-up results demonstrated sustained reduction. Novantrone is approved for treatment of pain in patients with advanced hormone-refractory prostate cancer and for initial therapy of acute non-lymphocytic leukemia