The FDA recorded a supplement on 16 September 2026 to new drug application 021560, Novartis's everolimus marketed as Zortress. The record does not state what the supplement concerns.
Zortress is the everolimus product licensed in the US for prevention of transplant rejection; everolimus for cancer is marketed under a separate application. This record therefore does not change oncology use of everolimus.
No change in prescribing follows until the revised label is posted.
- No change to everolimus use in oncology follows from this record
- Zortress is the transplant formulation; oncology everolimus has its own licence
- Check the revised FDA label for what the supplement changes
Why it matters
It is the only regulatory activity on this desk today, and it does not touch oncology practice.
Don't overread it
A supplement record is not a new indication or safety finding, and it concerns the transplant product.
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