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Novantrone Gets FDA Nod for Use in Advanced Prostate Cancer

Novantrone Gets FDA Nod for Use in Advanced Prostate Cancer

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.

Pivotal Study

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