Women With Breast Cancer No Longer Have to Settle for Second Class Treatments

FRIMLEY, England, August 11 /PRNewswire/ --

- Femara Endorsed Today by NICE for Postmenopausal Women With Early Breast Cancer After Surgery

Today the National Institute for Health and Clinical Excellence (NICE) published a positive Final Appraisal Document (FAD) on the class of breast cancer drugs known as aromatase inhibitors (AIs) post surgery. This final decision from NICE should ensure appropriate access to these latest life-saving treatments for the hundreds of thousands of postmenopausal women with breast cancer. Up until now, tamoxifen has been considered the 'gold standard' treatment in this setting.

Femara (letrozole) has been recommended for adjuvant (post-surgery) and extended adjuvant (after five years of tamoxifen therapy) use in early invasive oestrogen receptor-positive (ER+) breast cancer in postmenopausal women, in accordance with its licensed indications.

About 75% of all breast cancers in postmenopausal women are ER+ [1]. Femara is the only AI that these women can use before surgery, as initial treatment immediately after surgery, or after they have completed five years of tamoxifen therapy.

"Femara has the widest range of licenses because it has the trial evidence to demonstrate its effectiveness in all these settings," said Mr Rob Carpenter, Consultant Breast Surgeon, Barts and The London NHS Trust. "In addition, unlike other AIs, Femara has demonstrated greater benefit in women at increased risk of breast cancer recurrence. The BIG 1-98[2] trial demonstrated this increased effectiveness in high-risk women, with a 29 per cent reduction in risk of recurrence in women whose cancer had spread to the lymph nodes compared with tamoxifen" [3].

Another trial, known as MA-17, demonstrated the efficacy of extended adjuvant Femara use. Women taking Femara after five years of tamoxifen on the trial had their risk of breast cancer recurring reduced by 42 per cent[4].

Susan James, a breast cancer survivor from Manchester, was put on Femara as part of this trial, 'Coming to the end of tamoxifen therapy can be a very scary time for women as your chances of breast cancer recurring increase when you stop taking hormone therapy,' she explains, 'knowing that I am doing all I can to protect myself against my cancer coming back takes away a lot of the fear and I am delighted that other women will now have the opportunity to benefit from this treatment.'

The FAD includes an independent cost-effectiveness analysis conducted by NICE, which showed that for primary adjuvant treatment for five years, the costs per quality-adjusted life-year (QALY)[a] gained were GBP21,580 with Femara (letrozole) and GBP31,965 with anastrozole when compared with tamoxifen therapy for the same time period. NICE considered both treatments to be cost effective in comparison with tamoxifen. For extended adjuvant treatment, Femara use was even more cost effective - the cost per QALY of five years of Femara after five years of tamoxifen dropped to GBP9,760 compared with five years of tamoxifen followed by no treatment.

To address the lack of head-to-head data with AIs, Novartis recently announced the initiation of the FACE (Femara vs. Anastrozole Clinical Evaluation) trial. This is the first head-to-head study of these two aromatase inhibitors in the post-surgery setting and is expected to enrol 4,000 women worldwide. The trial will directly compare the efficacy of the two drugs in node positive patients who are at higher risk of their breast cancer returning.

"The superior efficacy of AIs over the Gold standard tamoxifen has raised questions over which one is the most effective in the adjuvant setting. This is why Novartis has made a significant commitment to sponsor this important study." said John Ketchum, Business Unit Director, Novartis Oncology UK.

The FAD will form the basis of the final guidance to the NHS on how to use AIs post surgery. If there are no appeals against the FAD, the final guidance on the use of aromatase inhibitors in early breast cancer is due to be published by NICE in November this year; formalising the recommendations.

Notes to Editors

Quick reference guide to licensed indications for AIs in the UK (middle three columns were included in the NICE review) Pre-surgery Post-surgery Within five Following (neoadjuvant) (adjuvant) years post- five years surgery of tamoxifen - switching therapy from tamoxifen post-surgery Advanced (adjuvant (extended breast switch) adjuvant) cancer First Second -line -line Femara Yes Yes Yes Yes Yes (letrozole) Anastrozole Yes Yes[b] Yes Yes Exemestane Yes Yes Yes

NICE Appraisal Committee's Recommendations[5]

The aromatase inhibitors anastrozole, exemestane and letrozole, within their licensed indications, are recommended as options for the adjuvant treatment of early oestrogen-receptor-positive invasive breast cancer in postmenopausal women.

The choice of treatment strategy (that is, primary adjuvant treatment with an aromatase inhibitor, switching from tamoxifen to an aromatase inhibitor or use of an aromatase inhibitor after completion of 5 years of tamoxifen treatment) should be made after discussion between the responsible clinician and the patient about the risks and benefits of the options available. Consideration of the strategy to be adopted should include whether the patient has received tamoxifen as part of their treatment so far, the side-effect profiles of the individual drugs and, in particular, the assessed risk of recurrence.

About Femara

Femara is now 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[6].

A once-a-day oral AI, Femara 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 (extended adjuvant)

- 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 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

References

[a]: a QALY is a common health economics tool that is used to compare the impact of treatments taking into account effects on quality of life. One QALY is equal to one year of perfect health. If illness impairs quality of life, then the value of each year is reduced accordingly (e.g. one year may equal 0.75 of a QALY)

[b]: the unplanned switch licence for Arimidex was not considered in the FAD, as this license was granted after the deadline for submissions to NICE for consideration had passed

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[1]. Breast Cancer Care website. http://www.breastcancercare.org.uk/content.php?page_id=442 (last accessed 10 August 2006)

[2]. 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

[3]. Monnier A. The evolving role of letrozole in the adjuvant setting: First results from the large, phase III, randomized trial BIG 1-98. The Breast 2006;15:S21-S29

[4]. Goss P. et al. Randomized trial of letrozole following Tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst 2005;97:1262-71

[5]. http://www.nice.org.uk/page.aspx?o=appraisals.inprogress.hormonesbc (add last accessed date)

[6]. Femara Summary of Product Characteristics. December 2005