FDA Approves Everolimus for Advanced Breast Cancer


Everolimus 159351-69-6Novartis gains FDA approval for Afinitor in advanced breast cancer marking a significant milestone for women battling this disease.

Everolimus CAS# 159351-69-6, is the active ingredient for AfinitorĀ®. Click for more information on, and availability of Everolimus. Also, click for more articles on breast cancer and the HER2 receptor.

  • 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
  • Approval represents the first major advance for US patients with advanced HR+ breast cancer since aromatase inhibitors were introduced more than 15 years ago
  • In a Phase III trial, Afinitor plus exemestane more than doubled the time women lived before the cancer worsened compared to exemestane alone
  • Afinitor, the first mTOR inhibitor approved for advanced HR+ breast cancer, is given after the disease progresses following prior therapy with letrozole or anastrozole

While everolimus improves progression-free survival in patients with hormone receptor-positive, HER2-negative metastatic breast cancer, it is highly toxic. Interest is now focused on promising late-stage pipeline candidates. Pfizer’s palbociclib and Novartis’ LEE011 are locked in a race to become the first-to-market CDK4/6 inhibitor. Both drugs are expected to improve survival when combined with an aromatase inhibitor in the first-line treatment of this patient segment and at a lower cost in terms of toxicity. The treatment of hormone receptor-positive, HER2-negative breast cancer will be transformed by the availability of these and PI3K inhibitors such as Pfizer’s buparlisib (BKM120).

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