WASHINGTON _ The FDA followed the advice of its OncologicDrugs Advisory Committee and approved the expanded use ofImmunex Corp.'s Novantrone Wednesday for the treatment of painassociated with advanced prostate cancer.

The approval comes six months after the company requested theexpanded use of the synthetic anthracenedinone and represents anentirely new treatment option for the sickest prostate cancer patients.

"Today's approval is a great advancement for patients with prostatecancer," said Robin Shapiro, manager of corporate communicationsfor the Seattle company. "We are really pleased that the FDA movedso swiftly _ it is a really good example of the FDA moving quicklyto bring new drugs to market for a disease that has few treatmentoptions."

Lodovico Balducci, a medical oncologist at the H. Lee MoffittCancer Center, in Tampa, Fla., called the drug "quite honestly amajor new advance in the treatment of hormone refractory prostatecancer."

Novantrone (mitoxantrone) was first licensed in 1987 for treatingacute myelogenous leukemia. The expanded application was given apriority review under the user fee guidelines, meaning the FDAagreed to take action on the drug in six months rather than thestandard 12 months. The advisory committee recommended approvalon Sept. 11 (see BioWorld Today, Sept. 12, 1996, p. 1). Immunexholds a U.S. patent on Novantrone until the year 2006.

More than 300,000 new cases of prostate cancer are expected to bediagnosed and 41,400 men are expected to die from the disease thisyear. Those with cancer that has spread beyond the prostate into thelymph nodes and bone are usually treated with hormone therapy.However, those cancers almost inevitably become resistant to thetreatment.

Once the cancer becomes hormone refractory _ resistant to hormonetherapy, the predominant symptom is near-debilitating pain.Novantrone, in combination with steroids, is the first chemotherapytreatment the FDA has approved for patients with hormone refractoryprostate cancer.

Canadian and U.S. clinical studies of the drug show that Novantroneand steroids significantly reduced the pain of hormone refractoryprostate cancer in 40 percent of patients. While the drug attacks thebone metastases, it does not appear to provide a survival advantage.

Nevertheless, Balducci noted that attacking the cancer is the beststrategy for reducing pain. "When you have pain the best way to getrid of it is to remove the source of the pain," said Balducci. "If youhave a log on your leg it is better to remove the log than to administermorphine. In prostate cancer, the metastasized cancer is the log."

Immunex currently earns $40 million to $45 million per year from thesales of Novantrone.

Wednesday's news came after the markets had closed. However, JaySilverman, an analyst with Schroder, Wertheim & Co., in New York,noted that "This approval will definitely help Immunex," butquestioned what this approval will mean financially for the company,because it is a therapy that only treats the pain and doesn't increasesurvival. "Will it make Immunex profitable? The jury is still out." n

-- Lisa Seachrist Washington Editor

(c) 1997 American Health Consultants. All rights reserved.