WILMINGTON, Del. -- Zeneca Inc. today announced that Zeneca Pharmaceuticals has received clearance from the Food and Drug Administration for the introduction of Zoladex (R) (goserelin acetate implant) 3.6 mg for the treatment of advanced breast cancer in premenopausal and perimenopausal women.(A)
The indication for advanced breast cancer is based on results of clinical trials involving more than 800 women in North America and Europe. Use of Zoladex in premenopausal and perimenopausal advanced breast cancer patients is an alternative to surgical removal of the ovaries.
W. James O'Shea, Vice President, Sales and Marketing, Zeneca Pharmaceuticals, said: "Zeneca is established as the No.1 company in the medical treatment of breast cancer because of the success of Nolvadex in treating this devastating disease. I am confident Zoladex will be welcomed by physicians treating women who wish to avoid removal of the ovaries."
The American Cancer Society estimates that about 182,000 women will be diagnosed with breast cancer in the US in 1995. About one third of women are premenopausal or perimenopausal at the time of diagnosis.
Zoladex, which is now approved in 72 countries for breast cancer in premenopausal and perimenopausal women, was introduced in the US for the treatment of advanced prostate cancer in 1989 and for the treatment of endometriosis in 1993. Sales of Zoladex in the US in 1994 were more than $60 million.
Zoladex, a gonadotropin-releasing-hormoneagonist given by injection once a month, treats breast cancer by lowering serum levels of estrogen to concentrations typical of postmenopausal women. This reduces the growth of estrogen-responsive breast tumors. Two thirds of breast tumors are believed to be estrogen-dependent. Zoladex provides response rates and survival benefits comparable to those achieved by surgical removal of the ovaries, a standard therapy for premenopausal and perimenopausal breast cancer patients. Zeneca Pharmaceuticals currently ranks No.2 worldwide in sales of anticancer products and intends to grow further with its commitment to providing improved treatments for the common solid tumors.
Zeneca Pharmaceuticals is a business unit of Zeneca Inc. In the US, Zeneca is a $2.5 billion bioscience company with 6,500 employees and 45 manufacturing and research and development sites in 29 states. Zeneca is part of the UK-based Zeneca Group PLC (NYSE:ZEN), a major $6.9 billion international bioscience business. (A) Full prescribing information available on request.
CONTACT: Zeneca Public Affairs | Judith Auchard, (302) 886-3638 | OR | Zeneca Pharmaceuticals | Karen Miller, (302) 886-7713
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