CHMP Recommends Approval of Everolimus for GI, Lung NETs


“Everolimus (Afinitor) has received a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) as a treatment for patients with progressive, unresectable or metastatic, well-differentiated nonfunctional gastrointestinal (GI) or lung neuroendocrine tumors (NETs).

“The positive opinion suggests the mTOR inhibitor everolimus is likely to be approved in this setting when the European Commission issues its final decision.

“CHMP based its recommendation on data from the phase III RADIANT-4 trial. In the study, median progression-free survival (PFS) was 11 months with everolimus versus 3.9 months with placebo, representing a 52% reduction in the risk of progression or death (HR, 0.48; 95% CI, 0.35-0.67; P <.00001).”

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