Afinitor is now approved to treat unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) NET of GI or lung origin in adults with progressive disease.
The approval was based on efficacy and safety data from a pivotal Phase III Radiant-4 study, which assessed Afinitor versus placebo in 302 patients with advanced, progressive, well-differentiated nonfunctional NET of GI or lung origin.
Patients were randomized 2:1 to receive a daily dose of Afinitor 10 mg or placebo, which was supplied as tablets.
Results demonstrated that Afinitor reduced the risk of disease progression by 52% compared to placebo. It increased median progression-free survival (PFS) by 7.1 months:
Median PFS by central review was 11 months in the Afinitor arm and 3.9 months in the placebo arm.
Earlier this year, Novartis secured from the US Food and Drug Administration for Afinitor to treat adult patients with progressive, well-differentiated nonfunctional NET of GI or lung origin that are unresectable, locally advanced or metastatic.
Afinitor (everolimus) tablets is approved in over 110 countries, including the US and in the European Union, for locally advanced, metastatic or unresectable progressive NET of pancreatic origin.
It is not indicated to treat patients with functional carcinoid tumors in the US.
Afinitor is also approved in certain countries for advanced HR+/HER2- breast cancer in combination with exemestane, after prior endocrine therapy.
Image: Afinitor product packaging. Photo: courtesy of Novartis AG.