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(Drug information on goserelin) acetate implant (Zoladex), currently marketed as a prostate cancer therapy.
The ODAC members recommended Zoladex as an acceptable alternative to oophorectomy for the palliative treatment of advanced breast cancer in pre- and perimenopausal women.
Gerard Kennealey, MD, senior director of oncology for Zeneca Pharmaceuticals Group, described two phase III clinical trials comparing Zoladex alone against ovarian ablation and against Zoladex plus tamoxifen(Drug information on tamoxifen) (Nolvadex).
C. Kent Osborne, MD, Southwest Oncology Group, San Antonio, reviewed a phase III trial of Zoladex against oophorectomy, as well as efficacy data from 16 phase II trials. In general, patients on Zoladex did at least as well as those in the control groups, he said.
Patients taking Zoladex had slightly more menopausal symptoms (hot flashes, vaginal dryness, and headache), and they tended to experience a greater incidence of tumor flare. However, the side effects of Zoladex were in general mild and transitory. The FDA and members of ODAC agreed that Zoladex has a well-established safety record.