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Femara Approved for Early Breast Cancer After Surgery

EAST HANOVER, N.J., December 28, 2005 -- Novartis announced today the US regulatory approval of Femara (letrozole) in a new indication as a treatment for use after surgery in postmenopausal women with hormone-sensitive early breast cancer (adjuvant setting).

The US approval was based on results of the Breast International Group (BIG 1-98) study, which were published for the first time in the December 29 issue of The New England Journal of Medicine (NEJM). BIG 1-98 compared the effectiveness and tolerability of Femara versus tamoxifen when used as initial therapy after surgery (adjuvant setting) in postmenopausal women with hormone- sensitive early breast cancer. The study included an analysis of disease-free survival in patients treated for a median of 24 months and followed for a median of 26 months. The BIG 1-98 study is ongoing, and further analyses on safety and efficacy are planned.

Femara reduced the risk of breast cancer returning by an additional 21% (p=0.002)* over the reduction offered by tamoxifen. Further, patients taking Femara showed a 27% (p=0.0012) reduction in the risk of the cancer spreading to distant parts of the body. While no survival advantage has been demonstrated, this is clinically relevant because women whose disease does spread to other sites (metastases) may be at greater risk of dying from their disease.

In addition to the overall findings, Femara demonstrated its greatest benefit in two groups of women at increased risk of recurrence. Femara reduced this risk by 29% in women whose breast cancer had already spread to the lymph nodes at the time of diagnosis and by 30% in women who had undergone chemotherapy. The data also showed that in these high-risk subgroups, Femara reduced the risk of cancer spreading to distant parts of the body by 33% and 31%, respectively.

"Femara has consistently demonstrated superior efficacy against tamoxifen as first-line therapy in women with locally advanced or metastatic breast cancer, as well as in the adjuvant setting. In addition, Femara provides a notable benefit to patients who are at especially high risk of having their breast cancer return," said Diane Young, MD, vice president and global head of Clinical Development at Novartis Oncology.

Femara is now the only medicine in its class approved for use as an initial treatment immediately after surgery in postmenopausal patients with hormone-sensitive early breast cancer, and following completion of five years of tamoxifen therapy (extended adjuvant setting).

"One of the greatest fears confronted by women who have been treated for early breast cancer is that their cancer will come back. With Femara, we now have an option that can help address that fear early on, even in the patients who we know face the greatest risk of recurrence. Femara has proven to be a very important option in the treatment paradigm for postmenopausal women with hormone-sensitive early breast cancer," said Matthew Ellis, MD, PhD, FRCP, director of the Breast Cancer Program at Washington University and associate professor and section head of the Medical Oncology Division in the Department of Medicine at Washington University in St. Louis.

The approval of Femara for adjuvant use in the US was based on a six-month priority review. The FDA grants priority review to products that could potentially offer a significant improvement compared to marketed products in the diagnosis, treatment or prevention of disease, increased compliance or demonstrated efficacy in subgroups. Novartis recently received approval for this indication in the UK. Femara has also been submitted in the EU, Japan, and other countries. Additional approvals in other countries are expected in 2006.

About BIG 1-98

The BIG 1-98 study was a Phase III, randomized, double-blind study that compared the safety and efficacy of Femara vs. tamoxifen, when used as adjuvant therapy in postmenopausal women with hormone receptor-positive early breast cancer.

BIG 1-98 is the only clinical trial designed to incorporate both a head-to-head comparison of Femara with tamoxifen during the first five years following breast cancer surgery and a sequencing of both agents to determine the most effective approach to minimizing the risk of recurrence. BIG 1-98 was conducted by the International Breast Cancer Study Group (IBCSG) with many independent centers and was supported by Novartis.

About Femara

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 and the United States. The benefits of Femara in this setting are based on 24 months of treatment. In 11 countries, including the US and the UK, Femara has been approved for adjuvant use in postmenopausal women with hormone receptor-positive early breast cancer. The benefits of Femara in clinical trials are based on a median of 24 months of treatment and a median of 26 months of follow-up. Further follow-up will be needed to determine long-term outcome.

In addition, Femara is approved for the treatment of postmenopausal women with estrogen receptor-positive or estrogen receptor-unknown breast cancer that has spread to another part of the body (metastatic cancer). Not all indications are available in every country. Further follow-up is needed to determine long-term results, including side effects.

Important safety information

Patients should not take Femara if they are allergic to it 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 adjuvant setting, total cholesterol (generally non-fasting) in patients who had baseline values of total serum cholesterol within the normal range and then subsequently had an increase in total serum cholesterol of 1.5 ULN, was 173/3203 (5.4%) on Femara vs. 40/3224 (1.2%) on tamoxifen. Lipid lowering medications were used by 18% of patients on Femara and 12% on tamoxifen.

Commonly reported side effects were generally mild to moderate. Side effects seen in Femara vs. tamoxifen included: hot flashes (33.7% vs. 38%); joint pain (21.1% vs. 13.4%); night sweats (14.1% vs. 16.4%); and weight gain (10.7% vs. 12.9%). Other adverse events of importance included fractures (5.7% vs. 4%); myocardial infarction (0.6% vs. 0.4%); endometrial cancer (0.2% vs. 0.4%); second malignancies (1.9% vs. 2.4%) and thromboembolic events (1.2% vs. 2.8%).

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* 19% (p=0.003) in European filing due to slightly different definition of disease-free survival by FDA and European health authorities.

Source: Novartis

Posted: December 2005