FDA OKs New Use for Novartis’ Afinitor
The US Food and Drug Administration (FDA) has approved Novartis’ Afinitor (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Afinitor received a priority review designation providing a shortened review period for drugs that treat serious conditions and offer a significant improvement in safety or effectiveness.
Afinitor is also approved in 99 countries, including the US and throughout the European Union, for locally advanced, metastatic or unresectable progressive NET of pancreatic origin. It is also approved in more than 120 countries including the US and European Union for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy (in the US, specifically following sunitinib and sorafenib).
Afinitor is also approved in 102 countries including the US and European Union for advanced HR+/HER2- breast cancer in combination with exemestane, after prior endocrine therapy.