FDA approves new indication for Novartis’ Afinitor cancer drug

The tumors should be progressive, well-differentiated and non-functional. The data supporting the new indication was generated was based on a 302-patient trial comparing everolimus with placebo, both in combination with best supportive care.

Median progression-free survival was 11 months in the active-drug arm compared with 3.9 months for placebo.

Afinitor reduced the risk of progression in patients with progressive, well-differentiated, nonfunctional NET of GI or lung origin by 52%.

NETs are a rare type of cancer that start in neuroendocrine cells across the body, and are commonly identified in the GI tract, lungs or pancreas.

Novartis Oncology president Bruno Strigini said: "Afinitor is the first treatment approved for progressive, nonfunctional NET of lung origin, and one of very few options available for progressive, nonfunctional GI NET, representing a shift in the treatment paradigm for these cancers."

Further global regulatory filings for the new indication are underway, with a decision in the European Union (EU) expected later this year.

Afinitor is approved in 99 countries, including the US and throughout the EU, for locally advanced, metastatic or unresectable progressive NET of pancreatic origin.

Novartis has also secured approval for afinitor in over 120 countries for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor -targeted therapy.

Image: Afinitor Product Shot. Photo: courtesy of Novartis.