Source: DGNews  |  Posted 8 years ago

Data shows 52 per cent greater chance of responding to treatment with Femara than tamoxifen.

TORONTO, ON -- May 28, 2003 -- Novartis Pharmaceuticals Canada Inc. announced today that Health Canada has approved data that shows increased survival during the first two years of treatment among women taking Femara(*) (letrozole) compared directly to those taking tamoxifen. Study data demonstrated that women who require hormonal treatment for advanced breast cancer will remain tumour free longer when taking Femara.

"Health Canada approval of this data provides support for the use of Femara. The data marks the first time a hormonal therapy has demonstrated a two-year survival advantage over tamoxifen for advanced breast cancer patients," said Dr. Maureen Trudeau, Head of Medical Oncology and Haematology at Toronto Sunnybrook Regional Cancer Centre. "Now that we have this supporting data, Femara should become a primary treatment option for women with advanced breast cancer, requiring hormonal therapy."

DATA SHOWS FEMARA IMPROVES SURVIVAL
The randomized, double-blind study of 907 postmenopausal women (453 on Femara; 454 on tamoxifen) was designed to compare Femara to tamoxifen in the treatment of advanced breast cancer. Survival data at one and two years show Femara to have a statistically significant survival benefit compared to tamoxifen.

The data also shows that since the beginning of the study (November 1996), more women who began therapy on Femara were still alive and free of tumour progression approximately five years later, compared to those started on tamoxifen. In addition, patients taking Femara had a 52 per cent greater chance of responding to treatment than patients treated with tamoxifen (response rates were 32 per cent versus 21 per cent), and the time for their tumours to progress was 57 per cent longer with Femara than tamoxifen.

This analysis also confirms that Femara significantly delays time to progression of disease to a median 9.4 months, as compared to a median 6.0 months for tamoxifen. Since the data demonstrated a delay in disease progression, the need for further therapy, such as chemotherapy, may also be delayed.

"The increased survival data demonstrates that Femara continues to show superiority over tamoxifen in terms of efficacy. The safety of Femara versus tamoxifen is also superior," said Dr. Jean-Marie Leclerc, Vice President Medical Affairs, Novartis Pharmaceuticals Canada Inc. "The Femara data is significant as it will help women with advanced breast cancer to live longer with a better quality of life."

IMPACT OF BREAST CANCER
This year, the Canadian Cancer Society estimates 21,200 new cases of breast cancer will be diagnosed. For women, breast cancer is second only to lung cancer as a leading cause of death due to cancer. In 2003, it is estimated that there will be 5,300 deaths due to breast cancer.(1)

References: (1) National Cancer Institute of Canada: Canadian Cancer Statistics 2003, Toronto, Canada, 2003

ABOUT FEMARA
Femara, an aromatase inhibitor, is an oral once a day first-line treatment for postmenopausal women with advanced breast cancer. Femara is currently available in more than 75 countries worldwide, with first-line approval already gained in more than 50 countries, including Canada. Femara is also approved as neo-adjuvant (pre-operative) therapy in 20 countries around the world.

(*) Femara is a registered trademark.

SOURCE: Novartis Pharmaceuticals Canada Inc