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Femara (Letrozole) Approved for Early Invasive Breast Cancer Post-Surgery

UK Leads Europe and US in Milestone Post-op Breast Cancer Treatment

FRIMLEY, UK -- December 8, 2005 -- Post menopausal women with early invasive breast cancer can now benefit from Femara(R) (letrozole) immediately after surgery following early approval of an adjuvant (post-surgery) licence by the Medicines and Healthcare Products Regulatory Agency (MHRA).

The threat of cancer returning is a major concern for many women following surgery and Femara has been shown to significantly reduce recurrence.(1)

The results of the BIG1-98 trial, a large study published earlier this year involving over 8,000 women with breast cancer showed that women taking Femara directly after surgery remained cancer free for longer versus those taking tamoxifen.(1) The MHRA has acted quickly on this data to allow appropriate women with breast cancer to be considered for Femara. This licence approval is ahead of the rest of the Europe and the US.

Data showed that compared to those taking tamoxifen Femara significantly improved disease free survival by 19% in all women taking it and by 29% in high risk women whose cancer had spread to the lymph nodes.(1) It also significantly reduced breast cancer recurrence by 28% in patients who had previously received chemotherapy and reduced overall risk of cancer spreading to other parts of the body by 27%.(1)

"This is an important milestone in the treatment of postmenopausal women with early invasive breast cancer, as it means there is now a wider range of treatment options for women at all stages of the disease," said Nigel Bundred, Professor in Surgical Oncology, Wythenshawe Hospital, Manchester.

Jenny Harrop, a Royal Marsden patient taking part in the trial, says "Being on this trial gives me the reassurance that I am doing all I can and has allowed me to feel extremely positive about my future. I hope this new licence means women can benefit from this treatment."

Liz Carroll, Head of Clinical Services, Breast Cancer Care stated, "This is further evidence that aromatase inhibitors could become the treatment of choice over tamoxifen in early invasive breast cancer. This trial indicates that more lives could be saved over the next decade by the use of such drugs. Many women with breast cancer, who could benefit, will welcome this news, as will the healthcare professionals treating them."

Femara is now the first and only aromatase inhibitor (AI) licensed for treatment across the entire breast cancer treatment spectrum - before surgery, directly post-surgery, after five years of standard tamoxifen treatment and in advanced cancer.(1)(2) A once-a-day oral aromatase inhibitor, it is currently indicated in the UK for:

- Adjuvant (post-surgery) treatment of postmenopausal women with hormone receptor positive invasive early breast cancer

- The treatment of early invasive breast cancer in postmenopausal women who have completed prior standard adjuvant tamoxifen therapy

- Newly diagnosed postmenopausal women with advanced breast cancer

- Postmenopausal women with advanced breast cancer in whom tamoxifen, or other anti-oestrogen therapy has failed

- Neoadjuvant (pre-operative) therapy in postmenopausal women with localised hormone receptor-positive breast cancer, to allow subsequent breast conserving surgery in women not originally considered candidates for breast conserving therapy

About breast cancer(3)
About one in nine women in the UK will develop breast cancer in their lifetime. Breast cancer is now the most common cancer in the UK. In 2000 around 40,500 cases were diagnosed in women. Most cases (approximately 80%) of breast cancer occur in postmenopausal women. Breast cancer is the second biggest cause of death from cancer among women in the UK. In 2002 12,840 women died from breast cancer, which is more than 1,000 per month.

REFERENCES:
1. Waldie E, Chaudri-Ross HA, Hackl W. Clinical study report CFEM345D 019 (BIG 1-98): A phase 3 study to evaluate letrozole as adjuvant endocrine therapy for postmenopausal women with receptor positive (ER and/or PgR) tumors. June 4, 2005. Novartis Pharma AG, Basel, Switzerland
2. Femara Summary of Product Characteristics. December 2005
3. Breast Cancer Care, Breast Cancer Facts and Statistics. Last accessed November 2005 www.breastcancercare.org.uk


SOURCE: Novartis

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