Scottish Women are the First to be Given More Hope in the Fight Against Early Breast Cancer

FRIMLEY, England, May 8 /PRNewswire/ -- Women with breast cancer in Scotland were given a much better chance of staying cancer-free today, following the Scottish Medicines Consortium's (SMC) recommendation of Femara(R) (letrozole) to treat postmenopausal women with hormone receptor-positive invasive early breast cancer immediately following surgery (adjuvant use). This decision makes women in Scotland the first in the UK to have a commitment from the National Health Service to fund Femara in this setting.

Mr. Mike Dixon, Consultant Surgeon at the Western General Hospital, Edinburgh says: "Aromatase inhibitors (and particularly Femara) have been shown to be more effective than tamoxifen on each occasion when they have been compared. The availability of Femara for use in the adjuvant setting provides doctors and patients with another very effective and well-tolerated treatment for postmenopausal women with hormone-sensitive early breast cancer."

This decision was made following the extension of Femara's adjuvant licence, which was awarded to Femara by the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2005. This extension was awarded three months earlier than expected due to the successful data from the BIG 1-98[1] trial showing that Femara provides a significant advantage in disease-free survival (a) over the current 'gold-standard' treatment tamoxifen, when used directly after surgery in postmenopausal women with hormone receptor-positive early breast cancer. Compared with tamoxifen, the results revealed that Femara significantly improved disease-free survival by 19 per cent and was particularly effective in high-risk women, showing a 29 per cent reduction in recurrence in women whose cancer had spread to the lymph nodes.

"Having had both chemotherapy and surgery, I am now taking just one pill each day, which provides me with the reassurance that I am doing all I can to help prevent the cancer returning. I am delighted that other women in Scotland will now be able to readily access Femara after surgery and can improve their chance of surviving this disease." says Jean Valente, patient at the Western General Infirmary, Glasgow.

Lorraine Dallas, Head of National Development for Breast Cancer Care Scotland said: "At Breast Cancer Care we talk to women with breast cancer throughout Scotland, and know that the threat of cancer returning, following surgery, is a significant concern for many. We are pleased that they will now have access to more treatment options, especially one that has shown such positive results in reducing recurrence."

Femara belongs to a class of drugs called aromatase inhibitors (AIs). Of this class, Femara is the first and only 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.

In the rest of the UK, women with breast cancer will have to wait an additional six months, until November 2006, when the National Institute of Clinical Excellence (NICE) will complete its review of Femara and other aromatase inhibitors.

Notes to Editors

Full advice from the SMC[2]

Letrozole (Femara(r)) is accepted for restricted use within NHS Scotland for the adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.

Letrozole has shown benefit over standard anti-oestrogen therapy in terms of disease-free survival, although a pre-planned sub-group analysis showed a statistically significant beneficial effect in node-positive patients but not node-negative patients. It offers an alternative to existing treatment and has a different range of adverse effects.

Another aromatase inhibitor is available for the same indication at a lower cost.

Treatment with letrozole should be initiated by a breast cancer specialist.

About the SMC

The role of the SMC is to provide advice to NHS boards and area drug and therapeutics committees across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and any major new indications for existing products. This advice helps NHS Scotland plan the rapid introduction of beneficial treatments and over time, will help to reduce postcode prescribing. The same role is carried out in England and Wales by the National Institute of Clinical Excellence (NICE). Additional information can be found at the SMC website: http://www.scottishmedicines.org.uk/

About Femara

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.[3] 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

BIG 1-98 Trial Details

This independent, Phase III, international randomised, double-blind, controlled clinical trial enrolled more than 8,000 postmenopausal women with early breast cancer in 29 countries. The median follow-up time was 26 months. The study was supported by Novartis.

BIG 1-98 is the only clinical trial designed to incorporate both a head-to-head comparison of Femara with tamoxifen during the first five years following breast cancer surgery and a sequencing of both agents to determine the most effective approach to minimise the risk of recurrence. In summary the trial divided into the following four arms:

- Five years of Femara

- Five years of tamoxifen

- Two years of Femara followed by three of tamoxifen

- Two years of tamoxifen followed by three years of Femara.

The SMC decision was based on the Femara and tamoxifen only (monotherapy) arms. Further results from the ongoing arms of the study, due in 2008, are expected to determine which treatment is more effective, monotherapy or sequential therapy, and which sequence is more effective.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com

About Breast Cancer Care Scotland

If anyone with breast cancer has concerns or would like a free factsheet on letrozole, they can contact the Breast Cancer Care Scotland helpline on +44(0)808-800-6000.

For further queries or information about Breast Cancer Care Scotland please contact the press office on +44-207-551-8033 or +44-207-551-8032.

(a) Disease-free survival (DFS), the primary efficacy endpoint in this study, is defined as the absence of invasive loco-regional recurrence, distant metastasis, invasive contralateral breast cancer, a second non-breast primary tumour, or death from any cause.

References

[1]. The Breast International Group (BIG) 1-98 Collaborative Group. A Comparison of Letrozole and Tamoxifen in Postmenopausal Women with Early Breast Cancer. N Engl J Med, 29 December 2005

[2]. http://www.scottishmedicines.org.uk/

[3]. Femara Summary of Product Characteristics. November 2005