FDA Approves Drug for Advanced Breast Cancer
The US Food and Drug Administration (FDA) has approved Afinitor(R) (everolimus) tablets for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ breast cancer) in combination with exemestane after failure of treatment with letrozole or anastrozole.
"Afinitor is the first and only treatment that boosts the effectiveness of endocrine therapy, significantly extending the time women with advanced breast cancer live without tumor progression," said Gabriel Hortobagyi, MD, Chair of Breast Medical Oncology, University of Texas MD Anderson Cancer Center. "This approval redefines the treatment and management of advanced hormone receptor- positive breast cancer, offering a critical new option for physicians and patients.”
Each year, an estimated 220,000 women globally will be diagnosed with advanced HR+ breast cancer, the most common form of the disease. In the United States, nearly 40,000 people are expected to be newly diagnosed with advanced breast cancer this year alone. Approximately 70% of all invasive breast cancers are positive for HR expression at the time of diagnosis.
The approval was based on a randomized, double-blind, placebo- controlled, multi-center trial called BOLERO-2 (Breast cancer trials of OraL EveROlimus-2), which evaluated 724 postmenopausal women with advanced HR+ breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole.