The European Commission approved the Swiss-based Novartis drug Afinitor for advanced gastrointestinal and lung neuroendocrine tumor treatment.
Here are five insights:
1. Afinitor is the first oral therapy in the European Union's 28 member states for this type of GI NET.
2. Afinitor's EU approval was based on a Phase III study's results showing Afinitor's safety and efficacy.
3. The study's results showed Afinitor reduced the risk of disease progression by 52 percent compared to the placebo group.
4. In February 2016, the FDA approved Afinitor to treat adult patients with progressive, well-differentiated nonfunctional NET of GI or lung origin that are surgically non-removable, locally advanced or metastatic.
5. Additional worldwide regulatory filings for Afinitor are currently underway.