Mental Health

Afinitor approved by EU to Treat Most Common form of Advanced Breast Cancer

By Christopher J. Cooper | Update Date: Jul 30, 2012 09:21 AM EDT

European regulators have given the go-ahead for a new drug to treat women with a certain type  of breast cancer. 

Afinitor is the first in a class known as mTOR inhibitors to be approved for post-menopausal women with advanced hormone-receptor positive, HER2-negative breast cancer. American health regulators also backed the drug as a breast cancer treatment.

Herve Hoppenot, President of Novartis Oncology, the drug maker, called the approval a milestone. 

"The approval of Afinitor is an important milestone marking the first major advance for women in the European Union with hormone receptor-positive advanced breast cancer since the introduction of aromatase inhibitors more than 15 years ago," Hoppenot said . "Treatment with Afinitor gives women a new option in the battle against this advanced form of breast cancer, where there remains a significant unmet need."

The approval is based on Phase III trial of more than 700 patients, which showed that those treated with Afinitor lived significantly longer before their disease progressed. 

Breast cancer is the second leading cause of cancer-related death among women, after lung cancer. Each year, an estimated 220,000 women globally will be diagnosed with HR+ advanced breast cancer.  Advanced breast cancer is comprised of metastatic breast cancer (stage IV) and locally advanced breast cancer (stage III). Metastatic breast cancer is the most serious form of the disease and occurs when the cancer has spread to other parts of the body, such as the bones or liver. Locally advanced breast cancer occurs when the cancer has spread to lymph nodes and/or other tissue in the area of the breast, but not to distant sites in the body. 

Researchers say the drug has the potential to redefine the way this common form of advanced breast cancer is treated.

On July 20, the U.S. Food and Drug Administration  approved the drug. 

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