Novartis Oncology Release: Femara Endorsed Post-Surgery For Women With Early Breast Cancer In Scotland...But Women In The Rest Of The UK Must Wait A Further 6 Months

FRIMLEY, England, May 8 /PRNewswire-FirstCall/ -- Women with breast cancer in Scotland were given a lifeline today following the announcement from the Scottish Medicines Consortium (SMC) that Femara(R) (letrozole) is now recommended in Scotland for postmenopausal women with hormone receptor-positive invasive early breast cancer directly following surgery (adjuvant use). However, for women in the rest of the UK, access to Femara in this setting through the NHS will be uncertain for at least a further six months when the National Institute of Clinical Excellence (NICE) will complete its review of Femara and other aromatase inhibitors.

Femara is the only aromatase inhibitor to be licensed across the whole treatment spectrum: before surgery, directly post-surgery, after five years of standard tamoxifen treatment and in advanced cancer. "It is a pity that women must wait for approval of aromatase inhibitors in other parts of the UK, however, in England, Wales and Northern Ireland they can receive these drugs in the interim if they have their oncologists' approval." says Mr. Rob Carpenter, Consultant Breast and Endocrine Surgeon and Associate Director of Cancer Services, St Bartholomew's Hospital, London.

Today's recommendation of Femara by the SMC follows the adjuvant licence extension 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 trial,[1] an independent, international study involving over 8,000 women. Femara demonstrated 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.

"I am taking part in the BIG 1-98 trial and the positive results are really encouraging. This is fantastic news for women in Scotland and I only hope that other women all over the UK will soon be able to benefit from this treatment." Janice Monk, patient at the Royal Marsden, London.

Not only are women in the UK waiting for a NICE decision on the use of Femara directly after surgery, they are also waiting for a decision on its use in early breast cancer following completion of five years of tamoxifen therapy. The SMC decision for Femara in this setting happened in March 2005, meaning that women in the rest of the UK have already been waiting for over a year longer. The NICE approval for the use of Femara following tamoxifen therapy is also expected in November 2006. This will be an important decision as most recurrences in women with breast cancer receiving adjuvant tamoxifen occur after five years.[2]

Emma Pennery, Nurse Consultant at Breast Cancer Care commented: "Aromatase inhibitors, such as Femara, are beneficial in all types of hormone receptor-positive, postmenopausal breast cancer, which represent around 80 per cent of all breast cancers. With new data increasingly showing these treatments to be more effective than tamoxifen, we hope to see a NICE appraisal that supports the use of aromatase inhibitors in the treatment of early breast cancer and equal access to the best treatment options for all breast cancer patients throughout the country."

Notes to Editors

Full advice from the SMC[3]

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.[4] 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 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

Breast Cancer Care has been one of the leading providers of breast cancer information and support across the UK for the past thirty years. If any woman with breast cancer has concerns or wants a free factsheet on Femara, they can contact Breast Cancer Care's free and confidential helpline - +44(0 )808-800-6000 or alternatively visit www.breastcancercare.org

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

References

(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.

[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]. Paul E Goss et al. Randomized trial of letrozole following tamoxifen as an extended adjuvant therapy in receptor positive breast cancer: Updated findings from NCIC CTG MA.17. Journal of the National Cancer Institute, vol 97, No 17, 7 September, 2005

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

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

Novartis Oncology

CONTACT: For further information, and interviews with breast cancerspecialists/patients, please contact: Fiona Turner, Novartis Oncology, Tel:+44-1276-698086, Fax: +44-1276-698427, Email: fiona.turner@novartis.com.Sabrina Gallon, Ruder Finn, Tel: +44-207-462-8965, Email:sgallon@ruderfinn.co.uk. Sarah Snee, Ruder Finn, Tel: +44-207-462-8906,Email: ssnee@ruderfinn.co.uk