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FDA Approves New Indication for Novartis’ Afinitor
The FDA has approved Afinitor (everolimus tablets) as a treatment for adults with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NETs) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced, or metastatic, Novartis has announced. Afinitor becomes the first approved treatment for patients with lung NETs and the first oral therapy for GI NETs.
The approval is the result of positive findings produced by a phase 3 prospective, double-blind, randomized, parallel-group, placebo-controlled, multicenter study (RADIANT-4) that evaluated the safety and efficacy of Afinitor. The primary outcome measure was progression-free survival (PFS) based on radiological assessment. Overall survival and best overall response rate were also examined. Afinitor reduced the risk of progression by 52% and increased median PFS by 7.1 months.
Progressive, nonfunctional GI and lung NETs are rare cancers that have poor prognoses and limited treatment options. NETs originate in neuroendocrine cells throughout the body and are most often found in the GI tract, lungs, or pancreas. The disease can be defined as functional or nonfunctional. Functional NETs are characterized by symptoms caused by the oversecretion of hormones and other substances. Nonfunctional NETs may be characterized by symptoms caused by tumor growth (i.e., intestinal obstruction, pain, and bleeding for GI NETs, or asthma, chronic obstructive pulmonary disease, and pneumonia for lung NETs).
Afinitor was previously approved for the treatment of locally advanced, metastatic, or unresectable progressive NETs of pancreatic origin and for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy. The drug is also approved in combination with exemestane for advanced hormone receptor-positive/human epidermal growth factor receptor-2 negative breast cancer after prior endocrine therapy.
Source: Novartis; February 26, 2016.