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Afinitor (everolimus; Novartis) Drug Overview 2019

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    Report

  • 30 Pages
  • March 2019
  • Region: Global
  • Citeline
  • ID: 4846108
Overview
Afinitor (everolimus; Novartis) is an orally available analog of the mammalian target of rapamycin (mTOR), which mediates the signal transduction pathways required for cell cycle progression from G1 to S phase. In a similar manner to other mTOR inhibitors such as Torisel (temsirolimus; Pfizer), Afinitor inhibits the mTORC1 protein specifically and has no effect on the mTORC2 sister protein. This results in selective inhibition of the Akt signaling pathway, which is highly involved in cell growth and survival.

Analyst Outlook
Since its first approval in 2009, Afinitor (everolimus) has grown into one of Novartis’s top blockbuster oncology drugs, with peak sales of $1.6bn in 2015. Within renal cell carcinoma (RCC), Afinitor is approved for the treatment of adults with advanced disease that has progressed on either Sutent (sunitinib; Pfizer) or Nexavar (sorafenib; Bayer/Amgen). While Afinitor’s sales began to decline in 2016, the approval of Lenvima (lenvatinib; Eisai/Novartis/Merck & Co) in combination with Afinitor has provided some relief. However, a sharp decline in sales is expected upon the launch of generic copies, with key patents protecting Afinitor expiring in the US (2020), EU (2019), and Japan (2018).

Table of Contents

OVERVIEW
  • Drug Overview
  • Product Profiles
  • Afinitor: Renal cell carcinoma (RCC)
  • Afinitor: Breast cancer: HR+/HER2-

LIST OF FIGURES
Figure 1: Afinitor for RCC – SWOT analysis
Figure 2: The author's drug assessment summary of Afinitor for RCC
Figure 3: The author's drug assessment summary of Afinitor for RCC
Figure 4: Afinitor sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
Figure 5: Afinitor for HR+/HER2- breast cancer – SWOT analysis
Figure 6: The author's drug assessment summary of Afinitor in HR+/HER2- breast cancer
Figure 7: The author's drug assessment summary of Afinitor in HR+/HER2- breast cancer
LIST OF TABLES
Table 1: Afinitor drug profile
Table 2: Afinitor Phase III data in RCC
Table 3: Afinitor ongoing trials in RCC
Table 4: Afinitor sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 5: Afinitor drug profile
Table 6: Afinitor pivotal trial data in HR+/HER2- breast cancer
Table 7: Afinitor late-phase trial data in HR+/HER2- breast cancer
Table 8: Afinitor ongoing clinical trials in HR+/HER2- breast cancer