Novartis' Femara decreases recurrence, metastasis of breast cancer in phase 3 study

By Angela McDaniels

Seattle, Dec. 13 - Novartis Pharmaceuticals Corp. said postmenopausal women with hormone-sensitive early breast cancer who switched to Femara (letrozole tablets) from placebo during a phase 3 trial experienced significant improvements.

Women who switched experienced a 69% reduction in the risk that their breast cancer would return, a 72% reduction in the risk that the cancer would metastasize and a 47% reduction in the risk of dying from the disease, the company said.

These observations need to be confirmed by additional analysis and follow-up, the company noted.

The analysis represents the first time that an aromatase inhibitor has demonstrated a benefit in starting therapy up to five years after the end of a patient taking tamoxifen, another medicine used in the treatment of hormone-related breast cancers, the company said.

The findings came from a new analysis of the placebo arm of the phase 3, double-blinded, randomized, multi-center trial. In 2003, compelling results of an interim analysis showed that Femara reduced the risk of breast cancer recurring by 42% compared to placebo, the company said.

This data prompted an independent data safety monitoring board to recommend the unblinding of study results. Since then, 1,655 women taking placebo have chosen to switch to Femara, while another 613 women did not pursue further treatment.

The data was presented at the 28th annual San Antonio Breast Cancer Symposium.

The trial was coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queens University in Kingston, Ont., with funding from the Canadian Cancer Society and support from Novartis.

Femara is a once-a-day oral aromatase inhibitor available in more than 90 countries. It recently received approval in the United Kingdom for the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. Approval for the adjuvant indication is expected in the United States before the end of the year and in other countries in 2006, the company said.

Based in Hanover, N.J., Novartis develops prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. It is an affiliate of Novartis AG.

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