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Approval of Zoladex Is Recommended for Advanced Breast Ca

April 1, 1995
Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 4 No 4
Volume 4
Issue 4

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.

Articles in this issue

First Results of Avicidin Trials
Chemo Patients Often Develop Menstrual Irregularities
Growth Factor Receptor Blockade Moving From Laboratory to Clinic
Controlled-Release AZT Gets FDA Go-Ahead for New Drug Investigation
Vinorelbine Plus Chemo Promising in Advanced Disease
Bone Substudy a Part of Tamoxifen Prevention Trial
Ultrasound Breast Screens Useful in Selected Women
New Roles Forecast for Endocrine Therapy
Antisense Drug Against BCL-2 Effective in Animal Cancer Models
Anticancer Drugs From Zeneca in Regulatory Phase of Development
Osteosarcoma Chemo Regimens Debated
Primary Chemotherapy Allows Breast-Conserving Surgery in French Study
Cancer Care, Inc. Sponsors Make-Up Clinics for Chemo Patients
$2 Billion Budget for NCI Proposed
Risk of Gyn Cancer Increases After Diagnosis of Breast Cancer

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