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U.S. Food and Drug Administration Approval Summary : Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy . UNLABELLED On December 12 , 2014 , the U.S. Food and Drug Administration ( FDA ) approved ramucirumab for use in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) with disease progression on or after platinum-based chemotherapy . Patients with epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving ramucirumab . This approval was based on an improvement in overall survival ( OS ) with an acceptable toxicity profile in a randomized , multicenter , double-blinded , placebo-controlled trial of 1,253 patients with metastatic NSCLC previously treated with a platinum-based combination therapy . Patients were randomized 1:1 to receive either ramucirumab in combination with docetaxel or placebo in combination with docetaxel . The primary endpoint was OS . Patients who received ramucirumab in combination with docetaxel had improved OS ( hazard ratio [ HR ] : 0.86 ; 95 % confidence interval [ CI ] : 0.75 , 0.98 ) . Median OS was 10.5 months on the ramucirumab plus docetaxel arm versus 9.1 months on the placebo plus docetaxel arm . The most frequent ( ≥ 30 % ) adverse reactions in ramucirumab-treated patients were fatigue , neutropenia , and diarrhea . The most frequent ( ≥ 5 % ) grade 3 and 4 adverse reactions in the ramucirumab arm were fatigue , neutropenia , febrile neutropenia , leukopenia , and hypertension . 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 docetaxel for the treatment of patients with metastatic non-small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy . This report specifically addresses the issues of safety in patients with squamous cell tumors , effect of treatment in elderly patients , and uncertainties regarding effects in patients with tumors harboring epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations .
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Intervention_Pharmacological
Ramucirumab
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Intervention_Pharmacological
ramucirumab
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
ramucirumab .
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Intervention_Pharmacological
ramucirumab in combination with docetaxel
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Intervention_Control
placebo
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Intervention_Pharmacological
with docetaxel
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Outcome_Mortality
OS .
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Outcome_Mortality
improved OS
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Outcome_Mortality
Median OS
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Outcome_Adverse-effects
fatigue , neutropenia , and diarrhea
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Outcome_Adverse-effects
neutropenia , febrile neutropenia , leukopenia , and hypertension
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Participant_Condition
metastatic non-small cell lung cancer ( NSCLC )
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Participant_Condition
epidermal growth factor receptor
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Participant_Condition
anaplastic lymphoma kinase genomic tumor aberrations
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Participant_Sample-size
1,253 patients
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Participant_Condition
metastatic non-small cell lung cancer
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Participant_Condition
squamous cell tumors
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Participant_Age
treatment in elderly patients
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Participant_Condition
tumors harboring epidermal growth factor receptor