To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Prostate Cancer Labeling Expanded for Novantrone URL: http://www.pslgroup.com/dg/2C60E.htm Doctor's Guide June 12, 1997
SEATTLE, June 12, 1997 -- The results of a recent study show that treatment with Novantrone(R) (mitoxantrone), in combination with corticosteriods, lowers levels of prostate-specific antigen (PSA) -- a "marker" used by many physicians and patients to monitor prostate cancer. It is the first chemotherapeutic agent to demonstrate a substantial decrease in PSA levels in a Phase III, randomized clinical trial. The FDA has authorized the addition of the results of the clinical trial to the Novantrone label. Novantrone is now the first chemotherapy product with labeling describing itspotential to reduce PSA levels. Novantrone, in combination with corticosteriods, was approved by the FDA last fall to relieve pain experienced by patients with advanced prostate cancer that is no longer responsive to hormone therapy. "There are two key things I monitor in patients with advanced prostate cancer -- their PSA level and their pain," said Judd W. Moul, M.D., a urologist at Walter Reed Army Medical Center in Washington, D.C., and associate professor at the Uniformed Services University in Bethesda, Maryland. "Unfortunately, many patients with advanced prostate cancer experience bone pain and concern about rising PSA levels. Novantrone may provide benefit in both instances -- alleviating pain and reducing PSA -- those are significant benefits for these patients." In a pivotal study, patients were given either prednisone (a corticosteroid commonly taken by advanced prostate cancer patients) or prednisone plus Novantrone. Thirty-three percent of the patients randomized to the Novantrone plus prednisone arm of the trial experienced a reduction of 50 percent or greater in their PSA levels for two consecutive follow-up assessments. Conversely, only nine percent of the patients in the prednisone-only arm experienced the same reduction in PSA levels. The FDA notes that the clinical significance of a fall in PSA after chemotherapy is unclear and these findings should be interpreted with caution because PSA measurement was not part of the original study plan. While Novantrone has been shown effective in reducing both pain and PSA levels, a direct correlation cannot be drawn. For example, of 26 evaluable patients randomized to the Novantrone plus prednisone arm who had a greater than or equal to 50 percent reduction in their PSA, 13 (50 percent) also experienced palliation of their pain. Among the 42 evaluable patients who received Novantrone plus prednisone but did not have this reduction in PSA, eight nonetheless had a primary palliative response. Side effects of Novantrone and corticosteriods are generally manageable. Those most frequently occurring (aside from expected effects on blood cells) were nausea (61 percent), fatigue (39 percent), hair loss (29 percent), loss of appetite (25 percent), constipation (16 percent), and difficulty breathing (11%). In addition, 5.5% of patients experienced events related to the heart. "Novantrone is an important weapon in the arsenal of the health care team -- oncologist, urologist, and nurse -- who care for the patient with advanced prostate cancer," said Richard Ghalie, M.D., medical director at Immunex. Since the approval last fall for the treatment of pain associated with advanced prostate cancer, a significant number of oncologists who care for these patients have prescribed Novantrone for pain relief. Now, they will have prescribing information which imparts valuable data about Novantrone's effect in lowering PSA levels as well." Immunex has launched a new, nationwide education program to help the 60,000 to 80,000 men with advanced prostate cancer deal with the distinct emotional and physical issues associated with their disease. "Empowered Patients in Control" (EPIC) offers two manuals, one for health care providers and another for patients and their families. EPIC manuals are free and are available by calling 800-220-6302. Immunex Corporation is a biopharmaceutical company engaged in developing immune system science in the areas of cancer, inflammatory and infectious diseases. American Home Products Corporation owns a majority interest in Immunex. AHPC is a research-based pharmaceutical and health care products company which develops, manufactures and markets of prescription drugs and over-the-counter medications. 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