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Novartisí drug for breast cancer recurrence to be given priority review in US



31 August, 2005: The US drugs authority has granted priority review to Femara (letrozole) as a post surgery treatment in breast cancer.

Novartis, the maker of the drug informed through a press release that the new indication will make Femara an adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 

The US Food and Drug Administration grants priority review to products that could potentially offer a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease.

The plea for consideration for priority review was made based on enhanced efficacy in high risk subgroups for which existing therapies have not demonstrated benefit. Specifically, Femara showed significantly improved efficacy compared with tamoxifen in women with node-positive disease and those who received chemotherapy treatment. Femara also demonstrated a significantly reduced risk of distant metastases compared with tamoxifen, the release said. 

If approved for this new indication, Femara will become the only breast cancer treatment approved in the US to significantly reduce the risk of recurrence for both the adjuvant setting and in extended adjuvant treatment following standard tamoxifen therapy. The supplemental new drug application for use of Femara in the adjuvant setting was submitted in June 2005. Novartis has submitted marketing applications for this indication globally.

The FDA submission is based on data from the Breast International Group (BIG) 1-98 study, a phase III, randomized, double-blind study that compared the safety and efficacy of adjuvant Femara vs. tamoxifen in more than 8,000 postmenopausal women with hormone receptor-positive early breast cancer.

The overall results of BIG 1-98 demonstrated that at a median follow-up of 26 months, Femara prolonged disease-free survival by reducing risk of recurrence by an additional 21% (p=0.002) over the reduction offered by tamoxifen. Women who were treated with Femara experienced a 27% reduction in the risk that their cancer would spread to other parts of the body (distant metastases) compared with tamoxifen (p=0.001), a clinically relevant finding since women who develop distant metastases may be at greater risk of dying from their disease. Femara also provided a 14% reduction in the risk of death, although this did not reach statistical significance (p=0.155).

In two separate pre-planned subset analyses, Femara also reduced the risk of cancer returning by 29% among patients whose initial cancer had already spread to the lymph nodes at the time of diagnosis (node-positive breast cancer) and by 30% in those who had received chemotherapy, two groups that are at increased risk of recurrence. Additionally, in node-positive patients and in patients who received adjuvant chemotherapy, the risk of distant metastases was reduced by more than 30% with Femara compared to tamoxifen.

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. Patients were randomized to the following arms: tamoxifen for five years, Femara for five years, tamoxifen for two years followed by Femara for three years, and Femara for two years followed by tamoxifen for three years. BIG 1-98 was conducted by the International Breast Cancer Study Group (IBCSG) with many independent centers and was supported by Novartis.

The adverse events in the BIG 1-98 study were consistent with published data on both Femara and tamoxifen. In the BIG 1-98 study, the two treatments were generally well tolerated and the safety profile in the two treatment arms overall was similar. Arthralgia/arthritis, bone fractures and osteoporosis were significantly more common with Femara treatment than with tamoxifen. Hot flashes/flushes, night sweats, vaginal bleeding, thromboembolic events and endometrial proliferative disorders were significantly more frequent in the tamoxifen arm.

Overall, more deaths were reported on tamoxifen (n=192) than on Femara (n=166). More patients on tamoxifen (n=154) than on Femara (n=111) died after a recurrence from cancer- and non-cancer-related causes. In patients whose breast cancer did not recur, more deaths due to cardiac causes were reported in the Femara arm than in the tamoxifen arm. In the trial, the number of all cardiovascular events was overall lower in the Femara arm than in the tamoxifen arm (9.7% vs. 10.5%). Irrespective of causality, the following adverse events occurred in both the Femara and tamoxifen groups: thromboembolic events, angina pectoris, myocardial infarction and cardiac failure. In the tamoxifen arm, there was a modest median decrease from baseline of 10-15% over 5 years in total serum cholesterol, compared with no change (0-7% median decrease) in the Femara arm. 

The frequency of bone fractures and osteoporosis on both treatments was low, but the numbers were higher in the Femara arm (fractures: 5.7%; osteoporosis 2.0%) compared to tamoxifen (fractures 4.0%; osteoporosis: 1.1%). Endometrial proliferative disorders were reported more often for tamoxifen (1.8%) than for Femara (0.3%).

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 indications are available in every country. 

In previous clinical trials, the most common adverse events experienced with Femara have been hot flashes/flushes, arthralgia/arthritis and myalgia. Other commonly reported adverse reactions are: nausea, fatigue, anorexia, appetite increase, peripheral edema, headache, dizziness, vomiting, dyspepsia, constipation, diarrhea, alopecia, increased sweating, rash, bone pain, weight increase, osteoporosis and bone fracture. 

Femara is contraindicated in women who are pregnant or breast-feeding as well as in premenopausal women. Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients, the release added

Novartis AG 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 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 83,700 people and operate in over 140 countries around the world.



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