Switzerland is first European country to approve use of Femara for post-menopausal women in extended adjuvant (post-tamoxifen) setting
Basel, 12 August 2004 1 Femara® (letrozole) has been approved in Switzerland via fast track procedure for the extended adjuvant treatment of postmenopausal women with hormone receptor positive or unknown early breast cancer who have received post-surgery tamoxifen therapy for five years, Novartis announced today. This approval by the Swiss Agency for Therapeutic Products (Swissmedic) makes Switzerland the first European country to have approved the extended adjuvant indication. The term extended adjuvant describes the period following the current standard five years of adjuvant treatment with tamoxifen.
"Novartis is very pleased that the Swiss health authorities recognize the importance of Femara in helping to reduce the ongoing risk of breast cancer recurrence among postmenopausal women who have survived breast cancer," said Diane Young, MD, vice president, global head, Clinical Development, Novartis Oncology. "We continue to work diligently with health authorities to make this indication available as soon as possible in the European Union, the United States, and around the world."
Even years after breast cancer diagnosis and primary treatment, the ongoing risk of breast cancer recurrence and mortality remains significant. Approximately one-third of women with estrogen receptor-positive early breast cancer will experience a recurrence, and more than half of these recurrences occur later than five years after surgery, according to the Early Breast Cancer Trialists Group, Oxford, UK.
The approval for the use of Femara in the extended adjuvant setting was based on the landmark MA-17 study, results of which were initially published in the online edition of the New England Journal of Medicine in October 2003. Coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University in Kingston, Ontario and supported by Novartis, the MA-17 study evaluated extended adjuvant treatment with Femara vs. placebo in nearly 5,200 postmenopausal women with early breast cancer.
Results from the final analysis of MA-17 were presented at the annual meeting of the American Society for Clinical Oncology (ASCO) in June 2004. The data showed that extended adjuvant treatment with Femara, following standard adjuvant tam-oxifen in postmenopausal women with early breast cancer, cut the risk of relapse by 42%.
At the median 2.5-year follow-up, a survival advantage had become apparent in those women whose cancer had already spread to lymph nodes at the time of diagnosis (node-positive). In this group of trial participants, which comprised approximately half of all patients in MA-17, deaths were reduced by a significant 39% vs. placebo. Patients with node-positive breast cancer are more likely to develop distant metastases and, therefore, may be at greater risk of dying from the disease.
Safety Data
The MA-17 study also included pre-planned sub-studies that assessed the effect of Femara on bone mineral density and lipid metabolism. While there was no significant difference between treatment groups in bone fractures, the authors noted more newly diagnosed cases of osteo-porosis in women taking Femara vs. placebo (6.9% vs. 5.5%; P=0.04).
Neither the core MA-17 protocol nor the lipid sub-study showed significant differences between the Femara and placebo groups in terms of cardiovascular events or lipid profiles.
Femara
Femara, an aromatase inhibitor, is an oral once-a-day first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. It is also approved for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy, and as neo-adjuvant (pre-operative) therapy. Novartis has filed for the extended adjuvant indication in the European Union and in countries around the world. In the United States, the Food and Drug Administration has granted the filing for this indication a priority review, and a decision is expected shortly. Femara is currently available in more than 80 countries worldwide. Not all indications are available in every country.
Contraindications and adverse events
The most common adverse events experienced with Femara are hot flushes, nausea, and fatigue. Other commonly reported adverse reactions are: anorexia, appetite increase, peripheral oedema, headache, dizziness, vomiting, dyspepsia, constipation, diarrhea, alopecia, increased sweating, rash, myalgia, bone pain, arthritis/arthralgia, and weight increase.
Femara is contraindicated in women who are pregnant or breast-feeding as well as in women with premenopausal endocrine hormone receptor status. Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 80 000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.
Additional information regarding Femara or Novartis Oncology can contact the websites www.femara.com or www.novartisoncology.com or additional media information can be found at www.novartisoncologyvpo.com.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by termino-logy such as "continue to work", "to make . available," "will," "likely to," "may be," "is expected", or similar expressions, or by express or implied discussions regarding potential new indications for Femara or potential future sales of Femara, or regarding the long-term impact of a patient's use of Femara. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Femara to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Femara will be approved for any additional indications in any market. Nor can there be any guarantee regarding potential future sales of Femara. Neither can there be any guarantee regarding the long-term impact of a patient's use of Femara. In particular, management's expectations regarding commercialization of Femara could be affected by, among other things, additional analysis of Femara clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the US 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 anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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Contacts
Eric Althoff
Novartis Pharma Communications
Tel. +41 61 324 6392
Fax +41 61 324 2224
eric.althoff@pharma.novartis.com
Nadine Schecker
Novartis Global Communications
Tel. +41 61 324 2710
Fax +41 61 324 9090
nadine.schecker@group.novartis.com
