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FDA Updates

FDA Approves Afinitor (Everolimus) for GI & Lung NETs

doi: 10.1097/01.COT.0000482575.83197.4b
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The U.S. Food and Drug Administration has approved Afinitor (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NETs) of gastrointestinal (GI) or lung origin that are resectable, locally advanced, or metastatic.

Approval of Afinitor for these indications was based on safety and efficacy data from the RADIANT-4, Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study of 302 patients with unresectable, progressive, well-differentiated, nonfunctional, locally advanced or metastatic NET of GI (excluding pancreatic) or lung origin. Patients were randomized two to one to receive daily Afinitor (10mg) or daily oral placebo, with all patients receiving best supportive care. The data showed patients receiving Afinitor had a median progression-free survival of 11 months compared with 3.9 months for patients receiving the placebo.

The most common adverse reactions for patients receiving Afinitor were stomatitis, diarrhea, peripheral edema, fatigue and infections; and the most common serious adverse reactions were stomatitis, diarrhea, fatigue, infections, and hyperglycemia.

Afinitor is marketed by Novartis.

Clinical Quick Facts

Drug: Afinitor (everolimus)

Approved Indication: Treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NETs) of gastrointestinal (GI) or lung origin that are resectable, locally advanced, or metastatic

Serious Side Effects: Stomatitis, diarrhea, fatigue, infections and hyperglycemia

Common Side Effects: Stomatitis, diarrhea, peripheral edema, fatigue, and infections

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