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Afinitor FDA Approval History

FDA Approved: Yes (First approved March 30, 2009)
Brand name: Afinitor
Generic name: everolimus
Dosage form: Tablets
Company: Novartis Pharmaceuticals Corporation
Treatment for: Renal Cell Carcinoma, Breast Cancer, Neuroendocrine Carcinoma

Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced HR+, HER2- breast cancer; progressive neuroendocrine tumors of pancreatic origin (PNET); progressive neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin; advanced renal cell carcinoma; and subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis.

Development timeline for Afinitor

DateArticle
Apr 12, 2018Approval FDA Approves Afinitor Disperz (everolimus) for Tuberous Sclerosis Complex-Associated Partial-Onset Seizures
Feb 26, 2016Approval FDA Approves Afinitor (everolimus) for Progressive, Nonfunctional Gastrointestinal and Lung Neuroendocrine Tumors (NET)
Aug 29, 2012Approval FDA Approves Afinitor Disperz - First Drug Formulated for Children with Rare Brain Tumor
Jul 20, 2012Approval FDA Approves Afinitor for Advanced Breast Cancer
Apr 26, 2012Approval Novartis drug Afinitor approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC
May  6, 2011Approval Novartis Gains FDA Approval for Afinitor As First New Treatment in Nearly Three Decades for Patients With Advanced Pancreatic NET
Nov  1, 2010Approval FDA Approves New Indication for Afinitor
Mar 30, 2009Approval Afinitor approved in US as first treatment for patients with advanced kidney cancer after failure of either sunitinib or sorafenib

See also

Afinitor (everolimus) Consumer information

Further information

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