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Wednesday 26th October 2016

EU approves new breast cancer drug

31st July 2012

The European Commission has given the go-ahead to a drug that targets advanced breast cancer of the kind most frequently diagnosed.


AfinitorR, manufactured by Swiss-based Novartis International, is being billed as the first major advance in the treatment of hormone receptor positive (HR+) and HER2 tumours in more than 15 years.

The drug is approved for use in combination with exemestane in women who have already come through the menopause.

According to Hervé Hoppenot, who heads Novartis' oncology division, the approval gives doctors a new option in the battle against this form of advanced breast cancer.

Based on randomised, double-blind, placebo-controlled multi-centred trials in more than 700 patients, the approval follows a similar green light from the Food and Drug Administration in the US, opening up further markets for Novartis.

According to Jose Baselga, head of haematology and oncology at the Massachusetts General Hospital, the drug has the potential to redefine the way this common form of advanced breast cancer is treated.

Around 220,000 women are diagnosed with HR+ advanced breast cancer around the world every year, and most will be offered endocrine therapy under current treatment guidelines.

However, endocrine therapy frequently results in resistance, while Afinitor works to target the mTOR pathway in cells, that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism.

Advanced breast cancer is comprised of metastatic breast cancer (stage IV) and locally advanced breast cancer (stage III).

Metastatic breast cancer occurs when the cancer has spread to other parts of the body, like the lungs or bone tissue, while locally advanced breast cancer involves a spread to the lymph nodes or other tissues in the area of the breast.

Women diagnosed with metastatic breast cancer have an approximate life expectancy of just 18-36 months, and most survive less than five years.

Afinitor is also known by its generic name, everolimus, and has already been approved in more than 80 countries.

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