Femara(r) Gains U.S. FDA Approval as Only Post-Tamoxifen Treatment for Early Breast Cancer
Basel, Switzerland (ots/PRNewswire)
- New Treatment Option the First to Help Postmenopausal Women With Early Breast Cancer Remain Cancer-Free Following Adjuvant Tamoxifen Therapy
Femara(R) (letrozole) is the first therapy approved by the U.S. Food and Drug Administration (FDA) for the extended adjuvant treatment of postmenopausal women with early breast cancer who have received adjuvant (post-surgery) tamoxifen therapy for five years, Novartis announced today.
"Femara truly provides hope to women who have survived early breast cancer by offering them an improved chance of remaining cancer-free," said Diane Young, M.D., vice president and global head of Clinical Development at Novartis Oncology. "This priority review approval marks the first time that nearly 100,000 women who complete tamoxifen therapy each year will have a medical option to reduce their ongoing risk of breast cancer recurrence."
The term extended adjuvant describes the period following adjuvant (post- surgery) treatment with tamoxifen. Even years after breast cancer diagnosis and primary treatment, the ongoing risk of breast cancer recurrence remains significant for all patients. Globally, approximately one-third of women with estrogen receptor-positive early breast cancer experience a recurrence, and over half of those recurrences occur more than five years after surgery. While tamoxifen is beneficial for five years post surgery, if used beyond that period, the risks associated with it outweigh the benefits. Extended adjuvant treatment with Femara is the first therapy to effectively reduce ongoing risk of breast cancer recurrence.
The approval for the extended adjuvant indication was based on results from the landmark, international, independent MA-17 study, which included more than 5,100 postmenopausal women and was coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University in Kingston, Ontario, Canada, and supported by Novartis. Initial results were published in the New England Journal of Medicine in October 2003.
The study showed that Femara reduced the risk of cancer coming back, or disease-free survival, by 38% and significantly increased a woman's chance of staying cancer-free. This is particularly important because when breast cancer recurs, it has very often spread beyond the breast (metastatic disease), which can have serious consequences. Femara also greatly reduced the chance of breast cancer returning to another part of the body, or distant metastases, by 39%.
About Femara
Femara is a leading once-a-day oral aromatase inhibitor that is also indicated for first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy, and as neo-adjuvant (pre-operative) therapy. Not all indications are available in every country. Novartis has filed in the European Union for the indication of extended adjuvant treatment of early breast cancer in postmenopausal women who have completed adjuvant (post-surgery) tamoxifen therapy. In addition to the U.S., this indication is now approved in the United Kingdom, Switzerland, Mexico, Korea and other countries around the world. Femara is currently available in more than 80 countries worldwide.
Femara contraindications and adverse events
The most common adverse events experienced with Femara are hot flushes, arthralgia/arthritis and myalgia. Other commonly reported adverse reactions are: nausea, fatigue, 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.
The foregoing release contains forward-looking statements that can be identified by terminology such as "provides hope," "will have," "offering ... improved chance," or similar expressions, or by express or implied discussions regarding potential future sales 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 reach any particular sales levels. 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; increased 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 U.S. 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.
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.com.
Additional information regarding Femara or Novartis Oncology can be found on the websites www.femara.com or www.novartisoncology.com. Additional media information can be found at www.novartisoncologyvpo.com.
Contact:
Contacts: John Gilardi Novartis Global Media Relations, Tel
+41-61-324-3018 (direct), or +41-79-596-1408 (mobile)
john.gilardi@group.novartis.com Kim Fox, Novartis Pharma
Communications, +1-862-778-7692 (direct) +1-917-415-2425 (mobile)
kim.fox@pharma.novartis.com