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LEADING BREAST CANCER MEDICATION CLEARED FOR USE IN MEN NEW INDICATION OFFERS VALUABLE ALTERNATIVE TO SURGERY

 WILMINGTON, Del., July 15 /PRNewswire/ -- ZENECA Pharmaceuticals, a business unit of ZENECA Inc., announced today that its leading antiestrogen agent, NOLVADEX(R) (tamoxifen citrate), was cleared by the Food and Drug Administration on April 1, 1993, for use in treating men with advanced breast cancer. Since its U.S. introduction in 1978, NOLVADEX has been used in women either as treatment for advanced breast cancer that has spread to other organs, or as adjuvant therapy to delay recurrence after surgery for early breast cancer.
 Following surgery to remove the primary tumor in the breast, standard first-line treatments for advanced breast cancer in men have included radiation therapy, orchiectomy (surgical removal of the testicles), and chemotherapy with cytotoxic agents. While the efficacy of orchiectomy as hormonal therapy is well established, many men find it psychologically traumatic and an unacceptable option. Moreover, the cessation of testosterone production that results from orchiectomy may cause reduced libido, impotence, and hot flashes.
 Because of the rarity of male breast cancer, controlled clinical trials have not been feasible. Nevertheless, clinical data clearly demonstrate the efficacy of NOLVADEX for palliation (symptom-reduction) of metastatic breast cancer in men.
 For example, in 1988, Ribeiro reported that 40 percent of 35 men treated with NOLVADEX showed objective responses (tumor regression), with a mean duration of 27 months.(1) Additional data from 87 men reported in more than 20 publications (including reviews by Patterson and colleagues(2) and Bezwoda and co-workers(3)) showed similar benefit. These data are supplemented by 16 case reports received by ZENECA. Clinical experience has shown that NOLVADEX is effective in male breast cancer patients whether or not they have had an orchiectomy.
 NOLVADEX is well tolerated in men, and its favorable side-effects profile enhances the attractiveness of this hormonal-therapy alternative to orchiectomy for the treatment of advanced male breast cancer. Among the most frequent side effects reported are mild nausea, constipation, and occasional hot flashes; side effects rarely require discontinuation of therapy.
 Carcinoma of the breast in men occurs with less than 1/100th the frequency of breast cancer in women. The American Cancer Society estimates that 1,000 men will be diagnosed with breast cancer in 1993, and 300 will die of the disease. Breast cancer usually occurs at an older age in men than in women, developing most often beneath the nipple. Male breast cancer is biologically similar to female breast cancer but is generally more hormonally sensitive.
 Over the years, NOLVADEX has been included in extensive clinical research on breast cancer therapy in women. Clinical studies such as those conducted as part of the National Surgical Adjuvant Breast and Bowel Project, headed by Bernard Fisher, MD, of the University of Pittsburgh School of Medicine, have shown NOLVADEX to be effective in delaying disease recurrence in female breast cancer patients receiving adjuvant therapy, while maintaining a favorable safety profile. Recently the Early Breast Cancer Trialists Collaborative Group, under the direction of Richard Peto in the U.K., published a meta-analysis of more than 130 clinical breast cancer trials. In this report, adjuvant therapy with NOLVADEX was evaluated in 40 trials, including 30,000 patients, and was shown to significantly delay disease recurrence and reduce the incidence of new cancers in the opposite breast. The new indication for breast cancer in men is the result of ongoing efforts to fully explore the clinical uses of this important medication in the battle against breast cancer.
 NOLVADEX is produced and marketed by ZENECA Pharmaceuticals (formerly ICI Pharma). Since the U.S. introduction of NOLVADEX in 1978, the manufacturer has been committed to supplying the medication free to qualified patients who cannot otherwise afford it. Under its Patient Assistance Program (PAP), the company has provided $52 million worth of NOLVADEX to more than 35,000 women with breast cancer. Men and women with breast cancer may request an application for the PAP either directly or through their physician. Applications may be obtained by calling toll-free 1-800-424-3727.
 ZENECA Pharmaceuticals (formerly ICI Pharma), a business unit of ZENECA Inc., has earned an outstanding reputation as an innovative research-intensive company dedicated to the highest standards of pharmaceutical discovery, development, and production. ZENECA Pharmaceuticals has approximately 3,000 employees, some 700 of whom are engaged in research, development, and quality assurance. The company's principal locations are in Delaware, with headquarters and research laboratories in Wilmington and manufacturing facilities in nearby Newark.
 Notes/References:
 (1) Ribeiro G: Tamoxifen (tam) for the treatment of advanced male breast cancer (mbc) (abstract). Proc Am Soc Clin Oncol 1988;7:22.
 (2) Patterson JS, Battersby LA, and Bach BK: Use of tamoxifen in advanced male breast cancer. Cancer Treat Rep 1980;64(6-7):801.
 (3) Bezwoda WR, Hesdorffer C, Dansey R, et al: Breast cancer in men: Clinical features, hormone receptor status, and response to therapy. Cancer 1987:60(6):1337.
 -0- 7/15/93
 /CONTACT: Jeffrey A. Soper of ZENECA Pharmaceuticals, 302-886-7433, or Kathy Phillips of Ruder Finn, 212-715-1631, for ZENECA Pharmaceuticals/


CO: ZENECA Pharmaceuticals ST: Delaware IN: MTC SU: PDT

LD -- NY007 -- 1805 07/15/93 09:32 EDT
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