Afinitor regulatory update

The European Commission approved Afinitor everolimus from Novartis in combination with Aromasin exemestane to treat postmenopausal women with hormone receptor-positive, HER2-negative breast cancer that has progressed after treatment with a non-steroidal aromatase inhibitor. Last month, FDA approved the oral mammalian target of rapamycin ( mTOR; FRAP; RAFT1) protein inhibitor for breast cancer (see BioCentury, July 23).

Novartis markets everolimus as Afinitor in the U.S. and EU to treat advanced renal cell carcinoma, neuroendocrine tumors of pancreatic origin and renal angiomyolipomas (non-cancerous kidney tumors), and as Afinitor in the U.S. and as Votubia in the EU to treat subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The pharma also markets everolimus as Certican to prevent transplant rejection in over 80 countries, and as Zortress in the U.S. to prevent organ rejection of kidney transplants in adults. ...