WILMINGTON, Delaware--Zeneca Pharmaceuticals has received FDA
approval to market Zoladex (goserelin acetate implant) for use in
combination with the antiandrogen flutamide (Eulexin) prior to and
during radiation therapy for the management of early-stage prostate
cancer (stages B2-C).
This indication makes Zoladex the first and only hormonal treatment
in its class (LHRH analogue) approved for combination treatment of
early-stage prostate cancer, the company said. The approval of the
supplemental new drug application, which includes both the 3.6 mg
monthly depot and the 10.8 mg 3-month depot formulations, marks a
broadening of the agents existing indication for the palliative
treatment of advanced prostate cancer.
The approval was based on an RTOG study of 466 patients with locally
confined prostate cancer randomized to receive Zoladex and flutamide
plus radiation or radiation alone. Disease-free survival was
significantly increased in the combination group (4.4 years vs 2.6
years for the radiation alone group, P < .001). Combination
therapy also resulted in a trend toward a reduction in metastases
(27% vs 36% at 4 years).