Zeneca Submits SNDA In USA For Zoladex

Zeneca Pharmaceuticals has submitted a Supplemental New Drug Application to the US Food and Drug Administration for the use of Zoladex (goserelin) in the treatment of advanced breast cancer in pre-menopausal and peri-menopausal women.

The SNDA for advanced breast cancer, says the company, is based on results of clinical trials involving more than 800 women in North America and Europe. Zeneca says that Zoladex will provide an excellent partner for its anticancer agent Nolvadex (tamoxifen). The product, which is currently available in 36 countries for pre- and peri-menopausal breast cancer, functions by lowering serum levels of estrogen to concentrations typical of post-menopausal women.

Michael Carter, International Marketing Director for Zeneca, said: "this SNDA for Zoladex aims at expanding treatment options and avoids the need for surgical removal of the ovaries." Dr Carter also emphasized the convenience to the patient of a delivery system requiring administration only once every 28 days.