Novartis Pharmaceuticals Corporation announced that the supplemental new drug application for FemaraÒ
(letrozole tablets) as first-line therapy in postmenopausal women with advanced breast cancer has been designated for priority review by the U.S. Food and Drug Administration (FDA). Femara, an aromatase inhibitor, is currently indicated for use as second-line therapy for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Priority review status is granted by the FDA to products that are considered to be a potential therapeutic advance over existing therapies. Actions taken on drugs given a priority review generally are made within six months. Novartis submitted the supplemental new drug application (sNDA) for Femara to the FDA on July 11. Regulatory submissions for this indication have also been filed globally in Europe, Canada, Switzerland and Japan.
"Novartis Oncology believes Femara will represent a therapeutic advance in the treatment of advanced breast cancer. We are proud of the priority review designation," said David Epstein, President, Novartis Oncology.
The filing is based on results of a study of more than 900 women evaluating Femara and tamoxifen in patients with metastatic breast cancer. Data from the trial will be presented in the U.S. at the Chemotherapy Foundation Symposium in New York, November 8-11 and at the San Antonio Breast Cancer Symposium in San Antonio, December 6-12. The data also will be presented at scientific conferences in Europe, including the European Breast Cancer Conference in Brussels, Belgium in September and at the European Society of Medical Oncologists in Hamburg, Germany, in October.
Femara is an aromatase inhibitor. In postmenopausal women, the aromatase pathway in peripheral tissue is the primary source of circulating estrogens, which stimulate the growth of certain hormone-dependent cancer cells. Femara blocks the enzyme aromatase from converting adrenal androgens (primarily androstenedione and testosterone) to estrogen in peripheral tissues such as fat, liver, muscle, breast, and in the tumor itself.
The FDA approved Femara once-a-day oral therapy in 1997 for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Femara is available in more than 75 countries worldwide.
Contraindications and Adverse Effects
Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients. Most commonly reported adverse effects with Femara in the second-line trials have been musculoskeletal pain (21%), nausea (13%), headache (9%), arthralgia or joint pain (8%), fatigue (8%), vomiting (7%), and dyspnea or labored breathing (7%).
About Novartis OncologyPharmaceuticals
Novartis Oncology is a business unit of Novartis and is devoted to the discovery, development and marketing of novel products that improve the lives of cancer patients. A global innovator, Novartis Oncology has a significant development pipeline of groundbreaking treatments, such as STI571 for chronic myelogenous leukemia and ZometaÔ
(zoledronic acid for injection) for hypercalcemia of malignancy. It also offers important products for use in treating patients with advanced breast cancer, including ArediaÒ
(pamidronate disodium for injection) and FemaraÒ