Arimidex Receives EBC Approval

Arimidex – first new hormonal treatment for hormone dependent early breast cancer in postmenopausal women for nearly three decades. Postmenopausal women diagnosed with early breast cancer now have another treatment choice in the management of this disease.

In early-stage breast cancer (cancer which is confined to the breast and the surrounding lymph nodes), tamoxifen has long been established as the current ‘gold standard’ for adjuvant (additional) treatment after initial surgery to remove the tumour, in postmenopausal women with ‘hormone sensitive’ breast tumours, i.e. tumours that grow more rapidly in the presence of the hormone, oestrogen.

Tamoxifen works by blocking the uptake of oestrogen by the cancer cell, thereby starving it of its main nutrient. However, tamoxifen’s mode of action can also be associated with a small but important risk of cancer of the endometrium (the lining of the womb), and also with an increased risk of thromboembolic events, including deep vein thrombosis (DVT).

Anastrozole, an aromatase inhibitor, acts in a different way to tamoxifen by shutting down the production of oestrogen in postmenopausal women. Following its introduction in 1997, anastrozole has shown superior efficacy and a lower risk of certain side effects compared with tamoxifen in the treatment of patients with hormone-sensitive advanced breast cancer, thus challenging the position of tamoxifen as the gold standard treatment for advanced breast cancer in postmenopausal women.

Given this benefit in advanced breast cancer, the main purpose of the ATAC study was to establish if these benefits of anastrozole over tamoxifen would also be seen in postmenopausal patients with early-stage disease. ATAC provides the first results for the comparison of a new generation aromatase inhibitor with tamoxifen in this early breast cancer setting.

IMPORTANT ANNOUNCEMENTOn behalf of AstraZeneca please find following details relating to the recent Therapeutic Goods Administration approval of Arimidex for the adjuvant treatment for early breast cancer in postmenopausal women with oestrogen/progesterone receptor positive disease.

Arimidex is the first hormonal therapy to receive approval for the adjuvant treatment of early breast cancer in postmenopausal women for almost thirty years and provides women with early breast cancer another treatment choice for management of this disease.

AstraZeneca have prepared a fact sheet ‘Arimidex in early breast cancer – Information for patients’ to assist with queries you may receive from patients about the new indication.

An application has been submitted for PBS listing of Arimidex for use as an adjuvant treatment of hormone-dependant early breast cancer in postmenopausal women. Prior to PBS listing, the available options for accessing Arimidex for adjuvant treatment of hormone-dependend early breast cancer in postmenopausal women include private prescription or private health insurance.

From 1 May 2003 Arimidex will be PBS listed with a restricted benefit for use in Australia for hormone-dependant advanced breast cancer in postmenopausal women.

Should you have any further queries please feel free to contact the AstraZeneca Information Service on 1800 805 342 or AstraZeneca.information@astrazeneca.com.