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Novartis has better breast cancer treatment

Health Canada Approves First and Only Breast Cancer Treatment that Improves Disease-Free Survival Beyond Five Years of Diagnosis. Women now have FemaraŽ 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 FemaraŽ (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 FemaraŽ 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 FemaraŽ 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, FemaraŽ represents a major step forward in the treatment of breast cancer - I'm delighted to have FemaraŽ 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, FemaraŽ, can extend protection for breast cancer patients beyond five years. The effectiveness of FemaraŽ in the trial was so profound that an independent committee recommend that the investigators to disclose the results early in order to offer FemaraŽ 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. FemaraŽ 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."

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 FemaraŽ 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 FemaraŽ 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 FemaraŽ 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 FemaraŽ 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.

FemaraŽ 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.

FemaraŽ is currently available in more than 75 countries worldwide.



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