Approval of Zoladex Is Recommended for Advanced Breast Ca

April 1, 1995

ROCKVILLE, Md--In a nearly unanimous vote, the FDA's Oncologic Drugs Advisory Committee (ODAC) recommended that the agency approve a new indication for goserelin acetate implant (Zoladex), currently marketed as a prostate cancer therapy.

ROCKVILLE, Md--In a nearly unanimous vote, the FDA's OncologicDrugs Advisory Committee (ODAC) recommended that the agency approvea new indication for goserelin acetate implant (Zoladex), currentlymarketed as a prostate cancer therapy.

The ODAC members recommended Zoladex as an acceptable alternativeto oophorectomy for the palliative treatment of advanced breastcancer in pre- and perimenopausal women.

Gerard Kennealey, MD, senior director of oncology for Zeneca PharmaceuticalsGroup, described two phase III clinical trials comparing Zoladexalone against ovarian ablation and against Zoladex plus tamoxifen(Nolvadex).

C. Kent Osborne, MD, Southwest Oncology Group, San Antonio, revieweda phase III trial of Zoladex against oophorectomy, as well asefficacy data from 16 phase II trials. In general, patients onZoladex did at least as well as those in the control groups, hesaid.

Patients taking Zoladex had slightly more menopausal symptoms(hot flashes, vaginal dryness, and headache), and they tendedto experience a greater incidence of tumor flare. However, theside effects of Zoladex were in general mild and transitory. TheFDA and members of ODAC agreed that Zoladex has a well-establishedsafety record.