Products

Date: 2011-05-06

Type of information: Granting of a Market Authorisation in the US

Product name: Afinitor®

Compound: everolimus

Therapeutic area: Cancer - Oncology

Action mechanism: mTOR inhibitor. Everolimus is a selective mTOR (mammalian target of rapamycin) inhibitor. mTOR is a key serine-threonine kinase, the activity of which is known to be upregulated in a number of human cancers. Everolimus binds to the intracellular protein FKBP-12, forming a complex that inhibits mTOR complex-1 (mTORC1) activity. Inhibition of the mTORC1 signalling pathway interferes with the translation and synthesis of proteins by reducing the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic elongat

Company: Novartis (Switzerland)

Disease: advanced neuroendocrine tumors (NET) of pancreatic origin

Latest news:

• • On April 12, 2011, Novartis announced that FDA oncology advisory committee has voted unanimously in favor of everolimus to treat patients with advanced neuroendocrine tumors (NET) of pancreatic origin.
• • On April 8, 2011, Novartis announced that it has updated its supplemental New Drug Application (sNDA) to the FDA for Afinitor® (everolimus) tablets. The submission has been amended to only seek approval for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin. The original submission included a proposed indication for patients with advanced NET of gastrointestinal, lung or pancreatic origin. The decision by Novartis was based on feedback from the FDA.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2011-05-06

UE authorization:

Favourable opinion UE:

Favourable opinion USA: 2011-04-12

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes