FDAPresentationNDA21-661RSR13(efaproxiralsodium).pptVIP

FDA PresentationNDA 21-661RSR13(efaproxiral sodium);Review Team;Outline ;Proposed Indication;RT-009: Regulatory History;Description of Clinical Trials;RT-009: Treatment Plan;RT-009: Endpoints;RT-009: Eligibility Criteria ;RT-009: Tumor Histology ;Post-Randomization Systemic Treatment(RT-009 Overall Population);Post-Randomization Systemic Therapy(RT-009 Breast Subgroup);RT-009: Number of Brain Lesions at Baseline (Overall Population);RT-009: Number of Brain Lesions by Primary Site ;RT-009: Analysis of Survival;RT-009: Response Rates in the Brain According to Applicant (Overall Population);Cause of Death(RT-009 Overall Population);RT-009: Steroids Received(Overall Population);RT-009: Response Rate in the Brain According to Applicant;RT-009: Other Secondary Endpoints;RT-008;RT-009: RSR13 and Radiation Exposure;Oxygen Exposure for the Overall Population (RT-009);RT-009: All Grade Treatment-Emergent Adverse Events;RT-009: Grade 3 / 4 Adverse Events;Conclusions;Statistical Review of Efficacy;Areas of Major Statistical Issues;Overall Finding;Evidence of Efficacy in ITT Population;Evidence of Efficacy in ITT (Contd.);Adjusted Analyses;Applicant’s Description;Protocol / SAP Exploratory Analyses;Exploratory Covariate Adjusted Analysis;Exploratory Covariate Adjusted FDA Analysis – Treatment Effect (Control = 0 vs. RSR13 = 1);Summary of Overall Finding;Subgroup Findings;NSCLC/Breast Primary Subgroup Finding;Summary of NSCLC/Breast Primary Subgroup Finding;Breast Primary Subgroup Finding;Issue 1: In the absence of overall survival benefit, any subgroup advantage is questionable;Issue 2: Small Breast Primary Subgroup;Issue 3: Imbalances within Breast Primary Subgroup– Important Factors;Exploratory Breast Primary Subgroup Finding;Breast Primary Subgroup Finding;Multiplicity;Results from Single Study Persuasive?;Review of Results;Review of Results