ROCKVILLE, Md--The FDA has approved a new indication for Novan-trone (mitoxantrone), making it the first chemotherapy agent approved for the treatment of advanced hormone-refractory prostate cancer. Novantrone in combination with corticosteroids has been shown to reduce bone pain and stabilize or reduce reliance on analgesics in these patients without adversely affecting quality of life.
"As a urologist who works with medical oncologists to treat prostate cancer patients, I am excited about this new indication," Judd Moul, MD, of the Walter Reed Medical Center, said in an interview with Oncology News International. "It is a new concept to have a chemotherapy that works well for bone pain and can be of palliative benefit to patients with end-stage prostate cancer."
He said that results with Novantrone are often seen very quickly, with some patients getting pain relief within a day or so after administration. "It doesn't happen every time, but when it happens, it's certainly beneficial for both the patient and the physician," he said.
Novantrone, marketed by the Immunex Corporation, Seattle, Washington, was first approved in the United States in 1987 for the treatment of acute myelogenous leukemia (AML).
The supplemental application, submitted just 6 months ago, was given priority review status by the FDA under the user-fee guidelines, and was one of the first submitted after the FDA announced its initiative to speed cancer drug approvals in 1996.
Novantrone is also in phase II clinical trials in North America for the treatment of metastatic breast cancer and in phase I/II trials for non-Hodgkin's lymphoma.