Novartis International AG (NVS) said the European Commission has approved Afinitor (everolimus) tablets for treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer (HR+ advanced breast cancer), in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
The approval was based on the Phase III BOLERO-2 trial. The randomized, double-blind, placebo-controlled, multi-center study of 724 patients found that treatment with Afinitor plus exemestane more than doubled median progression-free survival, or PFS, to 7.8 months, compared to 3.2 months with exemestane alone, by local investigator assessment.
Besides, an additional analysis based on an independent central radiology review showed Afinitor extended median PFS to 11.0 months compared to 4.1 months. The most common grade 3-4 adverse reactions were stomatitis, infections, hyperglycemia, fatigue, dyspnea, pneumonitis and diarrhea.
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