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| |  FDA Approves Zoladex For Early Stage Prostate Cancer WILMINGTON, DE -- July 28, 1998 -- The United States Food and Drug Administration has approved Zeneca Pharmaceuticals’ Zoladex(R) (goserelin acetate implant) in combination with the antiandrogen flutamide prior to and during radiation therapy for the management of early stages of prostate cancer. This indication makes Zoladex the first and only hormonal treatment in its class (LHRH-A) approved for combination treatment against early stages of prostate cancer (Stages B2-C -- disease locally confined to the prostate gland). The approval of the supplemental new drug application, which includes both the 3.6mg monthly depot and 10.8mg three-month depot formulations, marks a broadening of the existing indication for the palliative treatment of advanced prostate cancer. The effects of Zoladex in combination with flutamide plus radiation therapy were studied in 466 patients (Group 1: 231 Zoladex + flutamide + radiation; Group 2: 235 radiation alone) with locally confined prostate cancer. Results of the multicentre, controlled clinical trial, conducted by the Radiation Therapy Oncology Group, showed that disease-free survival was significantly increased in Group 1 compared to Group 2 (4.4 versus 2.6 years). Inclusion of normal PSA level as a criterion to measure disease-free survival resulted in significantly increased disease-free survival in patients receiving combination therapy (2.7 versus 1.5 years). Group 1 had a significantly lower rate of local failure compared to Group 2 at four years (16 percent versus 33 percent). Combination therapy also resulted in a trend toward reduction in distant spread of disease (27 percent versus 36 percent at four years). Zoladex is a luteinizing hormone-releasing hormone analogue (LHRH-A), also known as gonadotropin-releasing hormone (GnRH) agonist. This type of hormone therapy causes a cessation in testosterone production and thereby reduces serum testosterone to castrate levels. Zoladex offers a nonsurgical alternative to orchiectomy (surgical removal of the testes) with similar effectiveness. Administered via injection into the fat just below the skin of the abdomen, the biodegradable implant, or depot" slowly dissolves, delivering the drug continuously over a period of four weeks (3.6-mg depot) or three months (10.8-mg depot). Zoladex has been established as primary endocrine therapy in clinical trials world-wide involving more than 8,200 cancer patients. Hot flashes are the most frequently reported side effect with Zoladex. Unspecified cancer-related pain and lower urinary tract symptoms were also common. Prostate cancer is the second most frequently occurring malignancy in American men (after skin cancer). It represents one-quarter of all newly diagnosed cancer cases and is the second leading cause of cancer death among men after lung cancer. The American Cancer Society estimates that 184,500 new cases of prostate cancer will be diagnosed in the United States in 1998 and that over 39,000 men will die from the disease. More than 80 percent of all cases are diagnosed in men over 65 years of age. Related Links: Zoladex, Zeneca Pharmaceuticals
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