(ChemotherapyAdvisor) – The U.S. Food and Drug Administration has approved everolimus (Afinitor) tablets for use in combination with exemestane (Aromasin) to treat postmenopausal women with advanced hormone-receptor positive (HR+), HER2-negative breast cancer who have disease recurrence or progression after treatment with letrozole (Femara) or anastrozole (Arimidex).

“This is the first approval from the class of drugs known as mTOR inhibitors for the treatment of postmenopausal women with advanced hormone-receptor positive breast cancer,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research in a press release. “Afinitor is another example of the value of continuing to study drugs in additional types of cancer after their initial approval.”

The approval represents the first major advance for US patients with advanced HR+ breast cancer since aromatase inhibitors were introduced more than 15 years ago, according to the Novartis Pharmaceuticals Corp., East Hanover, NJ, which markets everolimus.

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“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.”

The approval was based results of the global phase 3 randomized, double-blind, placebo-controlled BOLERO-2 trial in 724 women with advanced HR+ breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole. Treatment with everolimus plus exemestane led to a progression-free survival (PFS) of 7.8 months vs 3.2 months with exemestane alone (HR 0.45 [95% Cl: 0.38‒0.54]; P<0.0001) by local investigator assessment. By independent central radiology review, everolimus plus exemestane extended median PFS to 11.0 months vs 4.1 months (HR 0.38 [95% CI: 0.31‒0.48]; P<0.0001) with exemestane alone. The most common adverse reactions (≥30%) were stomatitis, infections, rash, fatigue, diarrhea, and decreased appetite. The most common grade 3-4 adverse reactions (≥2%) were stomatitis, infections, hyperglycemia, fatigue, dyspnea, pneumonitis and diarrhea.

Current indications for everolimus are for the treatment of patients with advanced renal cell carcinoma that has progressed after treatment with other cancer therapies, in adult patients with progressive advanced neuroendocrine tumors of pancreatic origin, for patients with renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery, and for adults and children with subependymal giant cell astrocytoma associated with TSC who require treatment but are not candidates for curative surgery.

FDA Press Release

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