Novartis announced that the FDA has approved Afinitor (everolimus) tablets for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ breast cancer) in combination with Aromasin (exemestane; Pfizer) after failure of treatment with Femara (letrozole; Novartis) or Arimidex (anastrozole; AstraZeneca). This is the first FDA approval for an mTOR inhibitor in the treatment of advanced HR+ breast cancer.

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 Femara or Arimidex.

This pivotal Phase 3 study found that treatment with Afinitor plus Aromasin more than doubled median progression-free survival (PFS) to 7.8 months, compared to 3.2 months with Aromasin alone (hazard ratio=0.45 [95% Cl: 0.38–0.54]; P<0.0001) by local investigator assessment. An additional analysis based on an independent central radiology review showed Afinitor plus Aromasin extended median PFS to 11 months compared to 4.1 months (hazard ratio=0.38 [95% CI: 0.31–0.48]; P<0.0001) with Aromasin alone.

Afinitor is already approved for the treatment of adult patients with advanced renal cell carcinoma after failure of treatment with Sutent (sunitinib; Pfizer) or Nexavar (sorafenib; Bayer and Onyx); for the treatment of progressive neuroendocrine tumors of pancreatic origin in adult patients with unresectable, locally advanced or metastatic disease; for the treatment of adult patients with renal angiomyolipomas and tuberous sclerosis complex (TSC), who do not require immediate surgery; and for the treatment of adult and pediatric patients, ≥3 years of age, with subependymal giant cell astrocytomas (SEGAs) associated with TSC who require therapeutic intervention but are not candidates for surgical resection.

Afinitor is available in 5mg and 10mg dosage strengths.

For more information call (888) 4-AFINITOR or visit