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news.The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Novartis' Afinitor (everolimus) tablets to treat select gastrointestinal (GI) and lung neuroendocrine tumors (NETs).
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The European Commission delivers its final decision within three months. It will be applicable to all 28 European Union member states and Iceland as well as Norway.
The committee’s decision was based on pivotal study showing everolimus significantly improved progression-free survival (PFS) and reduced risk of progression vs placebo.
Everolimus increased median progression-free survival (PFS) by 7.1 months. Median PFS by central review was 11 months in the everolimus arm and 3.9 months in the placebo arm
Novartis Oncology Development and Medical Affairs global head Alessandro Riva said: "This important milestone reinforces our long-standing commitment to the NET community by providing solutions to help improve outcomes for patients with these rare and difficult-to-treat cancers."
Earlier this year, the US Food and Drug Administration approved Afinitor to treat adult patients with progressive, well-differentiated, nonfunctional NET of GI or lung origin that are unresectable, locally advanced or metastatic.
The company said further global regulatory filings for this indication are underway.
Afinitor is also approved in over 100 countries including the US and European Union for advanced renal cell carcinoma and advanced HR+/HER2- breast cancer in combination with exemestane.