Novantrone Gets FDA Nod for Use in Advanced Prostate Cancer

December 1, 1996

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.

ROCKVILLE, Md--The FDA has approved a new indication for Novan-trone(mitoxantrone), making it the first chemotherapy agent approvedfor the treatment of advanced hormone-refractory prostate cancer.Novantrone in combination with corticosteroids has been shownto reduce bone pain and stabilize or reduce reliance on analgesicsin these patients without adversely affecting quality of life.

"As a urologist who works with medical oncologists to treatprostate cancer patients, I am excited about this new indication,"Judd Moul, MD, of the Walter Reed Medical Center, said in an interviewwith Oncology News International. "It is a new concept tohave a chemotherapy that works well for bone pain and can be ofpalliative 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 afteradministration. "It doesn't happen every time, but when ithappens, it's certainly beneficial for both the patient and thephysician," he said.

Novantrone, marketed by the Immunex Corporation, Seattle, Washington,was first approved in the United States in 1987 for the treatmentof acute myelogenous leukemia (AML).

The supplemental application, submitted just 6 months ago, wasgiven priority review status by the FDA under the user-fee guidelines,and was one of the first submitted after the FDA announced itsinitiative to speed cancer drug approvals in 1996.

Novantrone is also in phase II clinical trials in North Americafor the treatment of metastatic breast cancer and in phase I/IItrials for non-Hodgkin's lymphoma.

Pivotal Study

In a pivotal study conducted by Ian Tannock, MD, and his colleaguesat the University of Toronto, 161 patients with advanced hormone-refractoryprostate cance were randomized to receive prednisone alone orpredinosone with Novantrone.

The study, published in the Journal of Clinical Oncology, foundthat 38% of patients receiving Novantrone had a marked reductionin severe bone pain, which in some patients reduced their requirementfor pain medications by half. Only 21% of patients who had receivedprednisone alone achieved the same degree of pain relief.

Median duration of pain relief was four times longer for patientswho responded to Novantrone (8 months versus 2 months for thosewho received prednisone alone). There was no difference in survivalbetween the two treatment groups.

Novantrone was well tolerated in these patients. Adverse effectsinclude neutro-penia and the usual side effects associated withchemotherapy (nausea and vomiting, fatigue, and alopecia).

Said E. David Crawford, MD, of the University of Colorado, "Novantrone'sapproval is an important advance because physicians have had veryfew options to effectively manage hormone-resistant prostate cancer.Now we can offer a treatment that can reduce the pain of prostatecancer by working on the cancer itself."

In a press release, Us Too!, the Illinois-based prostate cancerpatient advocacy organization, called the agent "an importantaddition to the currently limited treatment options availableto patients with advanced disease." Said

Henry A. Porterfield, CEO of Us Too!, "Maintaining a goodquality of life is a key goal in treating late-stage prostatecancer patients. We are hopeful that new therapy developmentslike Novantrone will contribute to achieving this goal."