FDA gives additional approval to Novartis’ Afinitor

The U.S. Food and Drug Administration (FDA) recently approved a new indication for the Novartis drug, Afinitor (everolimus).

Specifically, the drug can now be used on neuroendocrine (NET) tumors of gastrointestinal or lung origin.

Afinitor was developed as a tablet used in the treatment of NET of pancreatic origin in addition to a number of other indications. 

The FDA granted Afinitor priority review due to its ability to treat serious conditions while offering vast improvements in safety and effectiveness. Afinitor is currently the only treatment for progressed, nonfunctional NET that has originated in the lungs approved by the FDA. The drug is also one of a very limited amount of treatment options for GI NET that has progressed and is nonfunctional.

Neuroendocrine tumors, a rare form of cancer, grow in the neuroendocrine cells, which are all over the body. These tumors are mostly found in the GI tract, lungs and pancreas. NET is defined either as functional or nonfunctional. Functional NET is caused when hormones and other substances are over-secreted. Nonfunctional NET is caused by the growth of tumors that obstruct the intestines, and cause pain and bleeding.

Afinitor has been proven as safe and effective for nonfunctional NET.