FDA Approves Everolimus for Advanced Breast Cancer


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 Afinitor®. 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).

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

  • Share:

LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

This website uses cookies. By using our site, you agree to our terms of service