U.S. FDA grants review of post-tamoxifen drug for early breast cancer.

2004 OCT 7 - (NewsRx.com & NewsRx.net) -- Novartis Oncology announced that its supplementary new drug application for Femara (letrozole) has been granted priority review by the U.S. Food and Drug Administration (FDA) for an indication in the extended adjuvant treatment of early breast cancer in postmenopausal women who have completed standard adjuvant (post-surgery) tamoxifen therapy.

The FDA grants priority review to products that appear to represent a significant advance for serious or life-threatening diseases. The application was filed at the end of April 2004. The priority review establishes an action date no later than 6 months after the filing date. Femara received its first approval for this new indication from the Mexican health authorities earlier this month. Novartis Oncology has also submitted marketing applications for this new indication in the European Union, Canada and Switzerland among other countries.

In women with early breast cancer, adjuvant therapy with tamoxifen has not been shown to provide additional benefit after 5 years and, traditionally, most women have not received treatment after completion of adjuvant tamoxifen therapy. More than half of the recurrences of breast cancer occur after the completion of standard adjuvant therapy with tamoxifen. Recurrence of breast cancer after initial treatment places patients at greater risk of developing distant metastases and of dying of the disease.

There is currently no post-tamoxifen ...