~ Femara® poised to become new first-line treatment gold standard ~
DORVAL, Quebec (May 23, 2001) -- Novartis Pharmaceuticals Canada Inc. announced today the approval of Femara® (letrozole tablets) as first-line treatment for advanced breast cancer in postmenopausal women by Health Canada. Data from the largest study ever to evaluate a hormone therapy in advanced breast cancer indicated that Femara® was significantly more effective than tamoxifen in multiple efficacy endpoints. The new indication for Femara® as first-line therapy has been granted following priority review. Priority review, in Canada, is granted for drugs intended to treat serious, life-threatening diseases that provide significantly improved efficacy over existing therapies.
Results of the first-line study showed that after one year of treatment, the number of women in whom breast cancer had not progressed was nearly 50 per cent greater in patients taking Femara® than in those taking tamoxifen.
"The approval of Femara® as a first-line therapy should lead to a significant change in the treatment of advanced breast cancer in postmenopausal women," said Dr. Jean Latreille, Hemato-Oncologist and Director of the Centre intégré de lutte contre le cancer de la Montérégie (C.I.C.M) Greenfield Park, Québec. "With such positive clinical trial results to support the first-line indication, we can expect, immediately, that aromatase inhibitors like Femara® will replace tamoxifen as the initial therapy for breast cancer patients with advanced disease."
Femara®, an aromatase inhibitor, is a once-a-day oral treatment approved for advanced breast cancer in postmenopausal women. Health Canada first approved Femara® once-a-day oral therapy in 1997 as second-line therapy for advanced breast cancer with disease progression following antiestrogen therapy.
Breast Cancer in Canada
In the year 2001, the Canadian Cancer Society estimates 19,500 new cases of breast cancer - approximately half of which will already be in an advanced stage when detected. Of the 19,500, approximately 5,000 will be in Quebec. For women, breast cancer is second only to lung cancer as a leading cause of death due to cancer. In 2001, it is estimated that there will be 5,500 deaths due to breast cancer, 1,450 of which will be in Quebec.1
"Femara® was the first breast cancer treatment to demonstrate consistent superiority over tamoxifen in multiple efficacy endpoints in a prospective study. Femara® will offer physicians and patients a drug that can make a significant impact on the treatment of advanced breast cancer," said Jean-Francois Pouliot, PhD, Medical Expert, Novartis Oncology.
Clinical Trials Demonstrate Superior Efficacy
Femara® versus tamoxifen in locally advanced (stage IIIB) disease, metastatic breast cancer, or recurrences not amenable to surgery or radiotherapy
The phase III trial upon which Health Canada approval was based was a head-to-head, randomized, double-blind multi-centre trial comparing Femara® with tamoxifen in more than 900 postmenopausal women who had locally advanced (stage IIIB) disease, metastatic breast cancer, or recurrences not amenable to treatment with surgery or radiotherapy.
The study demonstrated that Femara® delays progression of advanced breast cancer for 9.4 months, as compared to 6.0 months for tamoxifen (41 weeks vs. 26 weeks). Results also indicated significant differences between Femara® and tamoxifen with respect to overall tumour response rates (30 per cent vs. 20 per cent), rate of clinical benefit (49 per cent vs. 38 per cent) and time to treatment failure (9.1 months vs. 5.7 months/ 40 weeks vs. 25 weeks). Femara® and tamoxifen were equally well tolerated.
In this phase III randomized controlled trial of 324 postmenopausal women, patients with large localized or locally advanced breast cancer tumours were given Femara® or tamoxifen as pre-operative treatment to reduce tumour size before surgery. Clinical response rates after four months of pre-operative therapy were significantly better for Femara® than for tamoxifen (55 per cent vs. 36 per cent) and, as a result, more women on Femara® underwent breast-conserving surgery compared to tamoxifen (45 per cent vs. 35 per cent). After adjustment for tumour size, nodal involvement and age, the odds of undergoing breast-conserving surgery were increased by more than 70 per cent for Femara® compared to tamoxifen. In both studies, Femara® and tamoxifen were equally well tolerated.
Ongoing Canadian-led clinical trial
A study, chaired by Dr. Paul E. Goss, Associate Professor of Medicine, Princess Margaret Hospital and University of Toronto, is underway to determine the benefit of Femara® treatment for women who have previously received five or more years of adjuvant tamoxifen treatment. In this phase III, double blind study, patients are randomized to receive either Femara® 2.5mg daily or placebo, daily, for five years. The analysis of the study will focus on disease-free survival and overall survival; incidence of contralateral breast cancer; long-term safety; and quality of life. As a part of their ongoing commitment to breast cancer research, Novartis recently doubled the trial enrolment of MA-17 from 2,400 to 4,800 patients.
Contraindications and adverse effects
Femara® is contraindicated in patients who are premenopausal or who are pregnant or lactating, as well as in patients with known hypersensitivity to Femara® or any of its excipients. The most commonly reported adverse effects with Femara® in the first-line trials (>3 per cent) were hot flushes (16 per cent vs. 13 per cent), nausea (6 per cent for both), hair thinning (5 per cent vs. 3 per cent).
Forward-Looking Statements
This release contains certain forward-looking statements relating to the Company's business, which can be identified by the use of forward-looking terminology such as "should," "will" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of company products and anticipated customer demand for such products. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions.
Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Some of these are uncertainties relating to unexpected regulatory delays, government regulation or competition in general, as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
About Novartis
Novartis (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of $25.5 billion and invested approximately $3.5 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 67,600 people and operates in over 140 countries around the world.
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