U.S. Food and Drug Administration Approval Summary: Ramucirumab for the Treatment of Metastatic XXXX Following Disease Progression On or After @entity902 -Based Chemotherapy.

@entity1 @entity137 @entity101 @entity902 @entity706 @entity470 @entity5 @entity294 @entity1149 @entity1295 @entity1544 @entity1398 @entity1431 @entity1205 @entity1349
UNASSIGNED: : On December 12, 2014, the U.S. Food and Drug Administration (FDA) approved ramucirumab for use in combination with @entity1205 for the treatment of @entity1 with metastatic @entity1149 ( @entity1149 ) with disease progression on or after @entity902 -based chemotherapy. @entity1 with @entity470 or anaplastic @entity706 aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving ramucirumab. This approval was based on an improvement in @entity1349 ( @entity1349 ) with an acceptable @entity137 profile in a randomized, multicenter, double-blinded, placebo-controlled trial of 1,253 @entity1 with metastatic @entity1149 previously treated with a @entity902 -based combination therapy. @entity1 were randomized 1:1 to receive either ramucirumab in combination with @entity1205 or placebo in combination with @entity1205 . The primary endpoint was @entity1349 . @entity1 who received ramucirumab in combination with @entity1205 had improved @entity1349 (hazard ratio [HR]: 0.86; 95% confidence interval [CI]: 0.75, 0.98). Median @entity1349 was 10.5 months on the ramucirumab plus @entity1205 arm versus 9.1 months on the placebo plus @entity1205 arm. The most frequent (>= 30%) adverse reactions in ramucirumab-treated @entity1 were @entity1295 , @entity1398 , and @entity294 . The most frequent (>= 5%) grade 3 and 4 adverse reactions in the ramucirumab arm were @entity1295 , @entity1398 , @entity1398 , @entity1431 , and @entity101 . IMPLICATIONS FOR PRACTICE: This report presents key information on the U.S. Food and Drug Administration approval of ramucirumab, a monoclonal antibody targeting vascular endothelial growth factor receptor-2, given in combination with @entity1205 for the treatment of @entity1 with metastatic @entity1149 whose disease has progressed on or after @entity902 -based chemotherapy. This report specifically addresses the issues of safety in @entity1 with @entity1544 , effect of treatment in elderly @entity1 , and uncertainties regarding effects in @entity1 with @entity5 harboring @entity470 or anaplastic @entity706 aberrations.
