Femara monotherapy cut risk of distant metastases and demonstrated improved survival trend, according to NEJM paper.

Patients with hormone receptor-positive breast cancer who are treated after surgery with Novartis’  Femara® (letrozole) experience longer disease-free survival and have a lower risk of developing distant metastases than those given tamoxifen, according to the company.

The data is published in the August 20 issue of New England Journal of Medicine in a paper titled “Letrozole alone or in sequence with Tamoxifen for postmenopausl women with breast cancer.” 

An analysis of 8,000 patients in the BIG 1-98 study found that those given the Femara monotherapy, an oral aromatase inhibitor, for five years after surgery fared just as well in terms of disease-free survival as those given sequential treatment with tamoxifen and Femara.

In addition, the Femara monotherapy patients had a 15% lower risk of developing distant metastases and a 12% reduction in the risk of disease-free survival events compared to those given tamoxifen monotherapy over the same time period. There was also a 13% (non-statistically significant) reduction in the risk of death among Femara monotherapy patients. 

“Letrozole is the only aromatase inhibitor versus tamoxifen to demonstrate early and significant reduction in the risk of distant metastases, significant improvements in disease-free survival, and this suggestion in overall survival benefit in primary breast cancer patients,” comments Henning T. Mouridsen, M.D., Ph.D., professor of oncology at Copenhagen University Hospital and one of the BIG 1-98 trial investigators.

Novartis points out the Phase III BIG 1-98 study is the only clinical trial to conduct a head-to-head comparison of an aromatase inhibitor with tamoxifen and also a comparison with sequential treatment using an aromatase inhibitor and tamoxifen in the first five years after breast cancer surgery.

Femara is already available in over 100 countries including the U.S., Japan, and major European countries. In the U.S. it is approved as adjuvant therapy for postmenopausal women with hormone receptor-positive early-stage breast cancer, as extended adjuvant therapy for those who are within three months of completing five years on tamoxifen, as well as advanced breast cancer.

The drug is Novartis’ fourth biggest selling pharmaceutical. Net worldwide sales in 2008 were $1.13 billion (up 17%) from 2007.  U.S. sales for 2008 were $483 million (up 18%). Global sales of Femara in the first half of this year were $ 596 million, up 15% on the first half of 2008.

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