Pharmaceutical giant Novartis AG is seeking regulatory approval to market its anti-kidney cancer drug Afinitor as a treatment for breast cancer.
According to a study presented at the European Multidisciplinary Cancer Congress, Afinitor was more effective in preventing breast cancer from worsening in patients whose disease had spread following treatment as compared to the Pfizer drug Aromasin. In fact, Afinitor more than doubled the time to disease progression than Aromasin.
Based on these findings, Novartis is seeking regulatory approval for a breast cancer indication in both the United States and Europe. Currently in the US, Afinitor is indicated for the following:
- Advanced renal cell carcinoma patients after failure of treatment with sunitinib or sorafenib;
- Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) patients who require therapeutic intervention but are not candidates for curative surgical resection;
- Progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease.
While European approval seems likely with the presently available data, the US FDA will probably want to see more evidence before granting the new indication.
Further Reading
Afinitor (everolimus) tablets
Aromasin (exemestane) tablets
