EU approves Novartis Drug for More Cancers

  • (c) Novartis(c) Novartis

The European Commission has granted approval for Novartis’ Afinitor (everolimus) for treating unresectable or metastatic, well-differentiated non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin. Novartis said Afinitor is the first approved therapy in all 28 EU member states, plus Iceland and Norway, for this version of lung NET, and one of limited treatments available for this type of GI NET.

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. To date, there have been very few or no approved treatment options for these patients, said Bruno Strigini, president of Novartis Oncology.

The approval was based on a Phase 3 study which showed that Afinitor cut the risk of the cancer spreading by 52%. Up to 44% of patients with GI NET and 28% of those with lung NET have advanced disease at the time of diagnosis with poor prognoses.

The US Food and Drug Administration (FDA) gave the drug a green light for similar indications in February this year. Afinitor is also approved for pancreatic and kidney cancers, as well as advanced HR+/HER2-breast cancer in combination with exemestane. However, the drug has been facing growing competition from rival medicines such as Opdivo from Bristol-Myers Squibb and Cabometyx from Exelixis.


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