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.
Since its first approval in 2009, Afinitor (everolimus) has grown into one of Novartis’s top blockbuster oncology drugs, with peak sales of $1.6bn in 2015. Within renal cell carcinoma (RCC), Afinitor is approved for the treatment of adults with advanced disease that has progressed on either Sutent (sunitinib; Pfizer) or Nexavar (sorafenib; Bayer/Amgen). While Afinitor’s sales began to decline in 2016, the approval of Lenvima (lenvatinib; Eisai/Novartis/Merck & Co) in combination with Afinitor has provided some relief. However, a sharp decline in sales is expected upon the launch of generic copies, with key patents protecting Afinitor expiring in the US (2020), EU (2019), and Japan (2018).
LIST OF FIGURES
11 Figure 1: Afinitor for RCC – SWOT analysis
12 Figure 2: Datamonitor Healthcare’s drug assessment summary of Afinitor for RCC
13 Figure 3: Datamonitor Healthcare’s drug assessment summary of Afinitor for RCC
15 Figure 4: Afinitor sales for RCC across the US, Japan, and five major EU markets, by country, 2017–26
24 Figure 5: Afinitor for HR+/HER2- breast cancer – SWOT analysis
25 Figure 6: Datamonitor Healthcare’s drug assessment summary of Afinitor in HR+/HER2- breast cancer
26 Figure 7: Datamonitor Healthcare’s drug assessment summary of Afinitor in HR+/HER2- breast cancer
LIST OF TABLES
5 Table 1: Afinitor drug profile
7 Table 2: Afinitor Phase III data in RCC
9 Table 3: Afinitor ongoing trials in RCC
16 Table 4: Afinitor sales for RCC across the US, Japan, and five major EU markets, by country ($m), 2017–26
20 Table 5: Afinitor drug profile
21 Table 6: Afinitor pivotal trial data in HR+/HER2- breast cancer
22 Table 7: Afinitor late-phase trial data in HR+/HER2- breast cancer
23 Table 8: Afinitor ongoing clinical trials in HR+/HER2- breast cancer
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