BASEL (dpa-AFX) - Novartis (NVS) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for Afinitor (everolimus) tablets for the treatment of unresectable or metastatic, well-differentiated nonfunctional neuroendocrine tumors of gastrointestinal or lung origin in adults with progressive disease. The positive CHMP opinion was based on efficacy and safety data from a pivotal Phase III study, RADIANT-4.
In February, the US FDA approved Afinitor for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced or metastatic.
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