The aromatase inhibitor Femara® (letrozole) has received approval from the U.S. Food and Drug Administration (FDA) for a new indication: initial post-surgery treatment of early, hormone receptor-positive breast cancer in postmenopausal women.
The decision to approve Femara for this new indication was based on results from the BIG 1-98 study, a phase III clinical trial that compared Femara to tamoxifen as adjuvant therapy for early, postmenopausal breast cancer.
Compared to tamoxifen, Femara significantly reduced the risk of cancer recurrence, particularly distant recurrences. Femara also benefited women at increased risk of recurrence-those with cancer that had spread to the lymph nodes by the time of diagnosis and those who had undergone chemotherapy.
Previously, Femara had been approved for use after five years of tamoxifen in postmenopausal women with early, hormone receptor-positive breast cancer; for first-line treatment of locally advanced or metastatic breast cancer that is hormone receptor-positive or hormone receptor-unknown; and for advanced breast cancer in postmenopausal women that has progressed after anti-estrogen therapy.
Hormone receptor-positive breast cancer refers to cancers that are stimulated to grow by the circulating female hormones estrogen and/or progesterone. Treatment of hormone receptor-positive breast cancer often involves hormonal therapies that suppress or block the action of estrogen. These therapies include tamoxifen as well as the agents known as aromatase inhibitors. Tamoxifen acts by blocking estrogen receptors, whereas aromatase inhibitors (such as Femara) suppress the production of estrogen.
A statement from Diane Young, MD, vice president and global head of Clinical Development at Novartis, notes, “Femara has consistently demonstrated superiority against tamoxifen as first-line therapy in women with locally advanced or metastatic breast cancer, as well as in the adjuvant setting. In addition, Femara provides a notable benefit to patients who are at especially high risk of having their cancer return.”
Reference: Novartis International AG. Media Release. Femara Receives Approval as Initial Therapy for Treament of Postmenopausal Women with Early Breast Cancer After Surgery. December 28, 2005.