New breast cancer drug Femara will save lives

Dec 29 2005

Following the results of a worldwide study, U.S. regulators have given approval for the use of the drug Femara for women with early breast cancer directly after they have had surgery.

The study found Femara was of the most benefit to women with the highest risk of the cancer returning and advocates for the treatment have been campaigning for the speedy assessment of the new breast cancer drug in order to save lives.

The study found that in women whose cancer had spread to the lymph nodes, the drug reduced the risk of a recurrence of disease by 29% compared to the hithertoo preferred drug tamoxifen.

The study which was co-ordinated by the Senology Center of Eastern Switzerland in Kantonsspital, involved 8,000 women and directly influenced the decision early in December of the Medicines and Healthcare products Regulatory Agency (MHRA) to approve a licence for the use of the drug for post-menopausal women with early, hormone-positive breast cancer immediately after surgery.

Prior to the decision Femara only had approval for use in patients with advanced breast cancer and those who had had surgery followed by five years of treatment with tamoxifen, which is the current common treatment.

Femara is one of a class of drugs called aromatase inhibitors which stop the natural production of oestrogen, the hormone responsible for the growth and recurrence of many breast cancers.

Experts have been impressed with the drug's effectiveness and say it gives hope to women with a high risk of theit breast cancer recurring.

Many believe the results of using aromatase inhibitors over tamoxifen, in treating early invasive breast cancer, will mean many more lives could be saved.

However, some experts in the UK believe the approval process there needs to be sped up to a matter of days, as the NHS drug watchdog, the National Institute for Health and Clinical Excellence (NICE), will not decide whether the drug should be made widely available until autumn next year.

This has led to concern that cancer patients in some areas are being denied access to the newest drugs because of the financial limitations of NHS hospital trusts, which has prompted some patients to take legal action in order to make their health authority pay for the treatment.

The drug already has approval in Scotland for post-menopausal patients but only after they have been treated with tamoxifen.

The study is published in the New England Journal of Medicine.