WILMINGTON, Delaware--Zeneca Pharmaceuticals has received FDA approval to market Zoladex (goserelin acetate implant) for use in combination with the antiandrogen flutamide(Drug information on 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).