Fulvestrant gains E.U. marketing approval.

2004 APR 1 - (NewsRx.com & NewsRx.net) -- AstraZeneca has received European marketing approval for its new breast cancer drug Faslodex (fulvestrant).

The novel drug is indicated for the treatment of postmenopausal women with receptor-positive, locally advanced or metastatic breast cancer, for disease relapse or progression on or after therapy with an anti-estrogen such as tamoxifen. Faslodex was launched in the U.S. in May 2002 and in Brazil in July 2003.

The goal of treatment for women with advanced breast cancer is to achieve an effective disease response and to enable the patient to maintain good quality of life for as long as feasibly possible. Hormonal agents such as aromatase inhibitors and tamoxifen are standard therapy in postmenopausal women with advanced breast cancer, providing an effective and well-tolerated treatment option. In time, however, tumor cells can grow resistant to treatment with these hormonal therapies and as a result there is a need for new agents to which tumors are not resistant. Faslodex is an exciting new type of therapy, which brings new choices for women with advanced disease, extending the sequence of 'patient-friendly' hormonal therapies that can be used to control the disease, says AstraZeneca.

Faslodex is a novel therapy with a unique mode of action. It is an estrogen receptor antagonist with no agonist effects that binds, blocks, and degrades the estrogen receptor in breast cancer cells. This mode of action is different than that of aromatase inhibitors that work by reducing the amount of estrogen in a woman's body. It is works differently than tamoxifen, which blocks the estrogen receptor but which also has some estrogenic actions that can be associated with a number of unwanted ...