Content about Everolimus

September 4, 2012

The Food and Drug Administration has approved a new formulation of a cancer drug made by Novartis for a type of brain cancer in children, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new formulation of a cancer drug made by Novartis for a type of brain tumor in children, the agency said.

The FDA announced the approval of Afinitor Disperz (everolimus) tablets for oral suspension to treat a rare brain tumor called subependymal giant-cell astrocytoma, or SEGA. The agency said Afinitor Disperz, a new dosage form of the drug Afinitor, is the first pediatric-specific dosage form for a pediatric tumor to receive FDA approval.

August 13, 2012

An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas' Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

July 23, 2012

The Food and Drug Administration has approved a new use for a Novartis cancer drug.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a new use for a Novartis cancer drug.

The drug maker said Friday that the FDA had approved Afinitor (everolimus) combined with exemestane for postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer who have failed treatment with letrozole or anastrozole.

April 27, 2012

A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

EAST HANOVER, N.J. — A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

The FDA approved Afinitor (everolimus) tablets for treating the tumors, known as renal angiomyolipomas, in adults with TSC who don't require surgery. The drug already was approved to treat brain tumors known as subependymal giant cell astrocytoma, or SEGA, in patients with TSC.

May 6, 2011

The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

Novartis announced the approval of Afinitor (everolimus), saying it marked the first approval of a drug for advanced pancreatic NET in nearly 30 years. The drug already is approved for treating cancers of the kidneys and brain.

February 11, 2011

The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

SILVER SPRING, Md. —The Food and Drug Administration announced Friday the approval of Waltham, Mass.-based Thermo Fisher’s QMS Everolimus Immunoassay, a test that monitors the blood for levels of Novartis’ drug Zortress (everolimus).

Zortress is a drug used to prevent rejection of transplanted kidneys.

“QMS Everolimus is the first FDA-cleared test physicians can use to maintain appropriate levels of the immunosuppressant everolimus,” FDA Center for Devices and Radiological Health director Jeffrey Shuren said.

October 31, 2010

The Food and Drug Administration has approved a cancer drug for treating tumors associated with...

May 16, 2010

Sandoz got its hands on a collection of generic drug candidates as it agreed to...

January 25, 2010

Daniel Vasella will step down as CEO of Novartis to focus on his position as...