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Pediatric Review CLINICAL REVIEW Application Type 21-227 Submission Number S-021 Submission Code SE-5 Letter Date January 31, 2008 Stamp Date January 31, 2008 PDUFA Goal Date July 31, 2008 Reviewer Name(s) Yuliya Yasinskaya, M.D. (risk/benefit, efficacy, labeling) Julie-Ann Crewalk, M.D. (clinical trial safety) Eileen Navarro, M.D. (postmarketing safety) Review Completion Date July 10, 2008 Established Name Caspofungin acetate (Proposed) Trade Name Cancidas® Therapeutic Class Enchinocandin antifungal Applicant Merck Priority Designation P Formulation lyophilized powder for infusion Dosing Regimen 50, 70mg/m2 Indications ◦ Empiric therapy of fungal infections in febrile neutropenic patients, ◦ Treatment of candidemia and the following Candida infections: intra- abdominal abscesses, peritonitis, and pleural space infections, ◦ Treatment of esophageal candidiasis, ◦ Treatment of refractory invasive aspergillosis Intended Population Children 3 months to 17 years 1 Clinical Review Yuliya Yasinskaya, M.D., Julie-Ann Crewalk, M.D,, and Eileen Navarro, M.D. NDA 21-227, S-021 Cancidas® (caspofungin acetate) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT 6 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT 6 1.1 Recommendation on Regulatory Action.....................................................................................................6 1.1.1 Confirmation of efficacy 6 1.1.2 Confirmation of safety 9 1.2 Risk Benefit Assessment ..........................................................................................................................10 1.3 Recommendations for Postmarketing Risk Management Activities ........................................................10 1.4 Recommendations for other Post Marketing Study Commitments ..........................................................10 2 INTRODUCTION AND REGULATORY BACKGROUND 12 2.1 Product Information..................................................................................................................................12 2.2 Tables of Currently Available Treatments for Proposed Indications........................................................12 2.3 Availability of Proposed Active Ingredient in the United States..............................................................13 2.4 Important Safety Issues With Consideration to Related Drugs ................................................................13 2.5 Summary of Presubmission Regulatory Activity Related to Submission.................................................14 2.6 Other Relevant Background Information .................................................................................................16 3 ETHICS AND GOOD CLINICAL PRACTICES 17 3.1 Submission Quality and Integrity .............................................................................................................17 3.2 Compliance with Good Clinical Practices................................................................................................17 3.3 Financial Disclosures................................................................................................................................17 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES 18 4.1 Chemistry Manufacturing and Controls ...................................................................................................18 4.2 Clinical Microbiology...............................................................................................................................18 4.3 Preclinical Pharmacology/Toxicology......................................................................................................19 4.4 Clinical Pharmacology .............................................................................................................................19 5 SOURCES OF CLINICAL DATA 20 5.1 Tables of Clinical Studies.........................................................................................................................20 5.2 Review Strategy........................................................................................................................................21 6 REVIEW OF EFFICACY 21 6.1 Indication(s)..............................................................................................................................................25 6.1.1 Methods 30 6.1.2 Demographics 31 6.1.3 Patient Disposition 31 6.2 Discussion of Individual Studies ..............................................................................................................33 6.2.1 Study 043 33 6.2.1.1 Methods 33 6.2.1.2 Patient Disposition 45 6.2.1.3 Demographics and Baseline Characteristics 46 6.2.1.4 Efficacy in Invasive Aspergillosis (primary, secondary endpoints, and subgroup analyses) 51 6.2.1.5 Efficacy in Invasive Candidiasis (primary, secondary endpoints, and subgroup analyses) 54 6.2.1.6 Efficacy in Esophageal Candidiasis 58 6.2.1.7 MO Conclusion on Efficacy 59 6.2.2 Study 044 59 6.2.2.1 Methods 59 6.2.2.2 Patient Disposition 66 6.2.2.3 Demographic and Baseline Characteristics 68 6.2.2.4 Efficacy, Primary Endpoint, Sensitivity Analyses 73 6.2.2.5 Efficacy, Subgroup analyses 77 6.2.2.6 MO Conclusion on Efficacy 78 2 Clinical Review Yuliya Yasinskaya, M.D., Julie-Ann Crewalk, M.D,, and Eileen Navarro, M.D. NDA 21-227, S-021 Cancidas® (caspofungin acetate) 7 REVIEW OF SAFETY BY JULIE-ANN CREWALK, M.D. 79 7.1 Methods ....................................................................................................................................................79 7.1.1 Clinical Studies Used to Evaluate Safety 80 7.1.2 Adequacy of Data 81 7.1.3 Pooling Data across Studies to Estimate and Compare Incidence 82 7.2 Adequacy of Safety Assessments .............................................................................................................82 7.2.1 Overall Exposure at Appropriate Doses/Durations and Demographics of Target Populations 82 7.2.2 Explorations for Dose Response 84 7.2.3 Special Animal and/or In Vitro Testing 84 7.2.4 Routine Clinical Testing 85 7.2.5 Metabolic, Clearance, and Interaction Workup 85 7.2.6 Evaluation for Potential Adverse Events for Similar Drugs in Drug Class 85 7.3 Major Safety Results ................................................................................................................................87 7.3.1 Deaths 87 7.3.2 Dropouts and/or Discontinuations 97 7.3.3 Serious Adverse Events 99 7.3.4 Adverse Events of Special Interest 100 7.3.5 Submission Specific Primary Safety Concerns 103 7.4 Supportive Safety Results.......................................................................................................................103 7.4.1 Common Adverse Events 103 7.4.2 Laboratory Findings 105 7.4.3 Vital Signs 106 7.4.4 Electrocardiograms (ECGs) 106 7.4.5 Special Safety Studies 106 7.4.5.1 Systemic Infusion-Related Events 106 7.4.5.2 Concentration-Effect Relationships for AEs and Laboratory Abnormalities in Pediatric Patients 107 7.4.6 Immunogenicity 108 7.5 Other Safety Explorations ......................................................................................................................108 7.5.1 Dose Dependency for Adverse Events 108 7.5.2 Time Dependency for Adverse Events 109 7.5.3 Drug-Demographic Interactions 109 7.5.3.1 Gender 109 7.5.3.2 Race 109 7.5.3.3 Ethnicity 110 7.5.4 Drug-Disease Interactions 111 7.5.5 Drug-Drug Interactions 111 7.6 Additional Safety Explorations...............................................................................................................111 7.6.1 Human Carcinogenicity 111 7.6.2 Human Reproduction and Pregnancy Data 111 7.6.3 Pediatrics and Effect on Growth 111 7.6.4 Overdose, Drug Abuse Potential, Withdrawal and Rebound 111 7.7 Additional Submissions..........................................................................................................................112 8 POSTMARKETING EXPERIENCE 112 8.1 POSTMARKETING SAFETY by Eileen Navarro, M.D.:.....................................................................113 9 APPENDICES 121 9.1 References ..............................................................................................................................................121 9.2 Labeling Recommendations ...................................................................................................................123 Table 1 The efficacy data in pediatric patients with documented Candida and Aspergillus infections from Protocol 043 are compared with the corresponding efficacy data in adult patients. ...................................7 Table 2 The efficacy data in empiric therapy of presumed fungal infections in febrile neutropenic pediatric subjects from Protocol 044 compared with the corresponding efficacy data in adult patients...................7 Table 3 US marketed antifungals.............................................................................................................................12 3 Clinical Review Yuliya Yasinskaya, M.D., Julie-Ann Crewalk, M.D,, and Eileen Navarro, M.D. NDA 21-227, S-021 Cancidas® (caspofungin acetate) Table 4 Frequency of Common Adverse Drug Reactions and Laboratory Abnormalities Associated with the Echinocandins as reviewed by FDA ...............................................................................................................13 Table 5 Presubmission Regulatory History.............................................................................................................14 Table 6 Post submission
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