New clinical data shows dramatic benefits of Femara� for women with breast cancer even after prolonged period of no anti-cancer treatment
* New data from MA-17 study showed Femara use led to 69 percent reduction in risk of breast cancer returning even years after completing standard tamoxifen therapy
* Femara showed 72 percent reduction in risk of distant metastases in postmenopausal women with early breast cancer who switched to Femara after placebo in study
* Results reported by the National Cancer Institute of Canada Clinical Trials Group
Basel, December 13, 2005 - Women with hormone-sensitive early breast cancer who switched to Femara� (letrozole) from placebo as part of a landmark trial experienced significant improvements in overall survival, disease-free survival and distant metastases, according to data presented at the 28th annual San Antonio Breast Cancer Symposium in Texas.
The analysis represents the first time that an aromatase inhibitor has demonstrated a benefit in starting therapy up to five years after the end of a patient taking tamoxifen, another medicine used in the treatment of hormone-related breast cancers.
In this new analysis of the landmark MA-17 trial, postmenopausal women who switched from placebo to Femara experienced a 69 percent reduction in the risk that their breast cancer would return (recurrence). There also was a 72 percent reduction in the risk that the cancer would spread to a distant part of the body (metastasis). A 47 percent reduction in the risk of dying from their disease was also observed. These observations must be confirmed by additional analysis and longer-term follow-up.
“These data provide the first clinical evidence that women can benefit from Femara even years after the completion of tamoxifen therapy. The findings may have a substantial impact on the overall treatment outcomes for postmenopausal women with early breast cancer,” said Dr. Paul Goss, MD, Ph.D., of the Massachusetts General Hospital in Boston and the lead investigator of the MA-17 trial.
The findings came from a new analysis of women who had been in the placebo arm of the MA-17 trial. In 2003, compelling results of an interim analysis showed that Femara reduced the risk of breast cancer coming back by 42 percent compared to placebo. These data prompted an independent Data Safety Monitoring Board to recommend the unblinding of study results. Since then, approximately 1,655 women talking placebo have chosen to switch to Femara, while another 613 women did not pursue further treatment.
MA-17 is a Phase III, international, double-blinded, randomized, multi-center trial. It is coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University in Kingston, Ontario, Canada with funding from the Canadian Cancer Society and supported by Novartis.
The incidence of adverse events in the post-unblinding analysis was similar to that seen in the earlier MA-17 analysis. Key safety findings presented included fractures (3.2% in the Femara-switched group vs. 2.8% in the placebo group); patient-reported osteoporosis (3.9% vs. 1.6%); and cardiovascular disease (2.8% vs. 2.9%).
Femara is a leading once-a-day oral aromatase inhibitor currently available in more than 90 countries worldwide. Femara is approved for extended adjuvant treatment of early breast cancer in postmenopausal women who have completed standard adjuvant tamoxifen therapy in 57 countries worldwide, including Europe as well as the United States. In addition, it is 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 anti-estrogen therapy, and as neo-adjuvant (pre-operative) therapy. Not all of these indications are available in every country.
Femara recently received approval in the United Kingdom for the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. Approval for the adjuvant indication is expected in the US before the end of 2005 and in other countries in 2006.
Contraindications, warnings and adverse events
Patients should talk to their doctor if they are allergic to Femara or any of its ingredients. Femara should not be taken by women who are pregnant as it may cause fetal harm. Femara should be taken only by women who are postmenopausal. Some women have reported fatigue and dizziness with Femara. Patients should use caution before driving or operating heavy machinery until they know how Femara affects them. In the extended adjuvant setting, longer follow-up is needed to determine the risk of bone fracture associated with long-term use of Femara.
In the extended adjuvant setting, commonly reported side effects are generally mild to moderate. Those seen more often with Femara versus placebo were hot flashes (50% vs. 43%), joint pain (22% vs. 18%) and muscle pain (7% vs. 5%). Other side effects, which were comparable to placebo, include fatigue (34% vs. 32%), swelling due to fluid retention (18% vs. 16%), headache (20% v. 20%), increase in sweating (24% vs. 22%) and increase in cholesterol (16% vs. 16%). The percentage of patients on Femara versus placebo reporting a fracture was 5.9% vs. 5.5%. The percentage of patients reporting osteoporosis was 6.9% vs. 5.5%. Bisphosphonates, drugs to increase bone strength, were given to 21.1% of Femara patients and 18.7% of placebo patients. The safety profile in the switch patients was similar to the safety profile in patients receiving extended adjuvant treatment.
The foregoing release contains forward-looking statements that can be identified by terminology such as “dramatic benefits,” “can benefit,” “may have substantial impact,” “must be confirmed by additional analysis and longer-term follow-up”, “is expected”, or similar expressions, or by express or implied discussions regarding potential new indications, marketing approvals, or 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 be approved for any additional indications in any market, nor that it 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.
For more information
Additional information regarding Femara or Novartis Oncology can be found on the websites www.femarainfo.com or www.novartisoncology.com.
About the National Cancer Institute of Canada Clinical Trials Group
The National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), funded by the Canadian Cancer Society and based at Queen’s University in Kingston, Ontario, Canada, develops, conducts and analyzes national and international trials of cancer therapy, including trials for new cancer drugs, cancer prevention and supportive care to improve quality of life for people with cancer. Since its inception in 1971, the NCIC CTG has enrolled more than 40,000 patients from Canada and around the world in over 300 clinical trials.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group’s businesses achieved net sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 91,700 people and operate in over 140 countries around the world.
For further information please consult http://www.novartis.com.
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