Novartis’ Afinitor gets EU approval to treat cancerous gastrointestinal or lung tumors

pharmafile | June 2, 2016 | News story | Research and Development, Sales and Marketing Afinitor, Cancer, European Commission, Novartis, regulation 

Swiss drugmaker Novartis (VTX: NOVN) on Thursday said the European Commission has approved its Afinitor (everolimus) to treat cancerous gastrointestinal or lung tumors. 

Afinitor is the first approved therapy in all 28 countries of the European Union (EU), as well as Iceland and Norway.

 The drug is indicated for treating metastatic, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with progressive disease. Neuroendocrine tumors are a type of cancer that originate in neuroendocrine cells throughout the body, and most commonly arise in the GI tract, lungs or pancreas. 

Nonfunctional GI and lung NET are rare cancers often diagnosed at advanced stages and associated with poor prognoses. 

Bruno Strigini, president, Novartis Oncology, said: “With this decision, Afinitor is now approved in the EU to treat the three most common types of advanced NET.” 

The EU approval of the drug was based on efficacy and safety data from a Phase III study.

Afinitor is approved in in more than 110 countries, including the US and in the European Union, for locally advanced, metastatic or unresectable progressive NET of pancreatic origin. 

Anjali Shukla

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