If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Novantrone Offers Clinical Benefit for Advanced Prostate Cancer Patients GAITHERSBURG, Md., Sept. 11, 1996-- Immunex Corporation (Nasdaq: IMNX) today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) agreed today that Novantrone (mitozantrone)(R) offers a net clinical benefit for late stage prostate cancer patients. The committee's recommendation, although not binding, will be considered by the FDA in completing its review of the company's supplemental application. If cleared for marketing, Novantrone will be the first chemotherapy approved for treatment in late stage prostate cancer patients. The supplemental application, submitted just four months ago, was given priority-review status by the FDA under the user-fee guidelines, meaning the FDA agreed to review the application within six months, compared to the normal 12-month review. In addition, the Novantrone application was one of the first filed with the FDA after President Clinton announced his initiative to speed cancer drug approvals for life threatening diseases for which there is no currently approved therapy. "We are pleased the FDA has quickly reviewed Novantrone for late stage prostate cancer patients, many of whom have a greatly diminished quality of life due to debilitating pain and for whom current therapy does not adequately address their needs," said Richard Ghalie, M.D, and medical director for Immunex. "The data presented today show Novantrone can decrease pain, decrease use of pain medications, decrease PSA levels and can slow the progression of this deadly disease." Tom Bruckman, executive director of the American Foundation for Urologic Disease Inc. said, "Many people have great hope that chemotherapy, such as the one reviewed today, will be an important tool in the treatment and pain management of advanced stage prostate cancer. FDA approval of this product will be the first time a chemotherapy agent is licensed for use in this setting. It is helping us cross a new threshold in the treatment of prostate cancer." Novantrone was first licensed in 1987 for use in acute myelogenous leukemia. If Novantrone is approved by the FDA for use in advanced stage prostate cancer patients, it will be the only chemotherapy to be licensed in this setting. About Prostate Cancer The American Cancer Society estimates there will be 317,000 new cases of prostate cancer in the United States in 1996, and 41,400 deaths. Prostate cancer is the most frequently diagnosed malignancy and second leading cause of cancer death in men. The incidence of prostate cancer increases with age; more than 80 percent of all prostate cancers are diagnosed in men over age 65. If detected in early stages, prostate cancer patients have a high probability of five-year survival, but treatment options are limited for inoperable disease. Hormone treatment can control prostate cancer for long periods by shrinking the size of the tumor, but ultimately all patients progress, because tumor cells become resistant to treatment and continue to divide and metastasize, or spread. Patients who do not die of other causes eventually progress to hormone-resistant disease. Once a tumor ha metastasized, most often to pelvic lymph nodes and to bone, the dominant symptom is sever pain, which can be debilitating. Supportive care measures include analgesia, steroids or localized radiotherapy, but none of these is considered effective for all patients. Immunex is a biopharmaceutical company dedicated to developing immune system science to protect human health. The company's products offer hope to patients with cancer, inflammatory and infectious diseases. American Home Products (NYSE: AHP) owns a majority interest in Immunex. AHP is one of the world's largest research-based pharmaceutical and health care products companies and is a leading developer, manufacturer and marketer of prescription drugs and over-the-counter medications. It is also a leader in vaccines, generic pharmaceuticals, biotechnology, agricultural products, animal health care, medical devices and food products. Patients who want more information about Novantrone can call 1-800-220-6302.
|
