Immunex Novantrone

Executive Summary

Revision to company-proposed multiple sclerosis indication urged by FDA Peripheral & Central Nervous System Drugs Advisory Committee in unanimous vote for approval Jan. 28. Committee members suggested FDA emphasize that the drug is for slowing the accumulated neurological disability and reducing relapse rate in clinically worsening secondary progressive or relapsing remitting MS. Immunex is seeking an indication for Novantrone "to slow the progression of neurologic disability and reduce the relapse rate in patients with progressive multiple sclerosis." Novantrone is already approved for the treatment of acute non-lymphocytic leukemia and for patients with symptomatic hormone-refractory prostate cancer