Immunex' Novatrone Approved In USA

Immunex Corporation has been granted marketing clearance from the US Food and Drug Administration for Novantrone (mitoxantrone), its anticancer drug, in combination with steroids, for the treatment of pain associated with hormone-refractory prostate cancer. This is the first product to be approved for this indication. Novantrone is currently available in the USA for use in acute myelogenous leukemia.

Data from clinical trials demonstrated that Novantrone, in combination with steroids, was well-tolerated and was effective in reducing severe bone pain in 38% of patients. This compared to 21% relief in patients who received steroids alone. Pain relief lasted for approximately eight months in novantrone-treated patients compared to two months in the steroid-only group.