Women now have Femara® to reduce the risk of breast cancer recurrence and spread of the disease at a time when no treatment had been proven effective
Toronto, Ontario, April 11, 2005 -- For the first time, Canadian women have a treatment option to reduce the threat of breast cancer beyond the five years of current standard tamoxifen therapy. Health Canada has approved Femara® (letrozole) for the extended adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women who have received approximately five years of prior standard adjuvant tamoxifen therapy. The term extended adjuvant describes the period following the current standard five years of adjuvant treatment with tamoxifen.
The approval is based on the unprecedented results of a landmark Canadian-led clinical trial, known as MA-17, in which Femara® was shown to significantly reduce both the recurrence of breast cancer and distant metastases (spread of the disease) to the rest of the body after standard adjuvant treatment with five years of tamoxifen.
"The approval of Femara® means women have, for the first time, a treatment option where none existed before," explained Dr. Kathleen Pritchard, Professor, Department of Medicine
Faculty of Medicine, University of Toronto. "In my experience, Femara® represents a major step forward in the treatment of breast cancer – I’m delighted to have Femara® to offer to my breast cancer survivors."
The results of the international, Canadian-led MA-17 study, have gained world recognition over the past year. The study showed, for the first time, evidence that a treatment, Femara®, can extend protection for breast cancer patients beyond five years. The effectiveness of Femara® in the trial was so profound that an independent committee recommend that the investigators to disclose the results early in order to offer Femara® to women who were receiving placebo.
"We are thrilled that the government fast-tracked this approval, filling a treatment gap for women with breast cancer," said Dallas Petroff, executive director at Willow Breast Cancer Support & Resource Services. "Thanks to medical research and access to new treatment options, women with breast cancer continue to live longer and better lives."
Treatment for Breast Cancer … Before Today
Until recently, hormonal treatment options for preventing breast cancer from recurring after initial diagnosis was limited to only five years of tamoxifen treatment. Beyond the first five years, there were no treatment options available to reduce the risk of the breast cancer recurring. Femara® is the only agent to be approved in the extended adjuvant setting.
Standard therapy includes initial treatment (usually surgery, chemotherapy and radiation), followed by early adjuvant treatment with tamoxifen for five years. Unfortunately, use of tamoxifen for more than five years has been shown to have no additional benefit after five years – yet more than half of all recurrences occur after five years.
"I have been taking tamoxifen now for almost five years, so this news could not have come at a better time for me," said Colleen Montgomery, breast cancer survivor. "There is so much uncertainty when you are living with breast cancer. You know that the risk of recurrence is always there, but previously you only had five years of treatment. There is great relief knowing there is another treatment that helps protect you for even longer, while maintaining your quality of life."
Colleen is not alone. "So many women face great anxiety when they come to the end of their five years of treatment," explained Barbara Bone, vice president of development at Breast Cancer Society of Canada. "We are thrilled that a new milestone has been reached in the treatment of breast cancer by this medication that extends treatment and provides a longer period of protection against recurrence."
About Breast Cancer in Canada
Breast cancer is the most frequently diagnosed cancer among Canadian women, and, according to recent statistics, was expected to account for 5,200 deaths in 2004. There are approximately 151,000 Canadian women, or one per cent of the female population, living today who have been previously diagnosed with breast cancer.
"There is a staggering number of people for whom we previously did not have treatment for longer than five years, even though the risk of recurrence remains significant for 15 years and even longer from the time of original diagnosis," explained Dr. Pritchard. "The approval of Femara® for extended adjuvant treatment is welcome news for both physicians and patients in Canada."
About MA-17
The MA-17 study evaluated extended adjuvant treatment with Femara® vs. placebo in nearly 5,200 postmenopausal women with early breast cancer (1,404 women from Canada; 3,607 from the United States; and 176 from Europe). MA-17 results were published in the New England Journal of Medicine in November 2003, and presented at two internationally-attended medical meetings, the San Antonio Breast Cancer Symposium in December 2003 and the American Society of Clinical Oncology meeting in June 2004.
About Femara®
Femara®, an aromatase inhibitor, is an oral once-a-day drug indicated as first-line therapy in
postmenopausal women with hormone-receptor positive advanced breast cancer. On April 1, 2005, the Therapeutic Products Directorate of Health Canada (TPD) granted a Notice of Compliance with Conditions (NOC/c) for Femara® for use in the extended adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women who have received approximately five years of prior standard adjuvant tamoxifen therapy. TPD grants a notice of compliance with conditions (NOC/c) to ensure early market access to promising new drugs for diseases that are serious or life-threatening, or in this case, where no current therapy exists. This approval is conditional upon further confirmation of final follow-up clinical trial results.
Although the intended duration of extended adjuvant therapy with Femara® is 5 years, data on efficacy endpoints is limited to a median follow-up of 28 months. The clinical evidence collected to date demonstrates a statistically significant increase in disease-free survival, but no overall survival advantage has been consistently demonstrated.
Femara® is also indicated for the hormonal treatment of advanced/metastatic breast cancer in women with natural or artificially-induced postmenopausal status, who have disease progression following antiestrogen therapy.
Femara® is currently available in more than 75 countries worldwide.
Forward-Looking Statement
The foregoing release contains forward-looking statements that can be identified by terminology such as "first time," "milestone," "reduce the threat," "longer period of protection against recurrence," "only agent," "only treatment option," "extends treatment," 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; increased government 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.
