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761150Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 761150Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA/BLA Multi-disciplinary Review and Evaluation {BLA 761150} {MARGENZA, margetuximab-cmkb} NDA/BLA Multi-disciplinary Review and Evaluation Disclaimer: In this document, the sections labeled as “The Applicant’s Position” are completed by the Applicant, which do not necessarily reflect the positions of the FDA. [FDA will complete this section.] Application Type Biologics License Application (BLA) 351(a) Application Number(s) 761150 Priority or Standard Standard Submit Date(s) December 18, 2019 Received Date(s) December 18, 2019 PDUFA Goal Date December 18, 2020 Division/Office Division of Oncology 1 Review Completion Date December 15, 2020 Established Name Margetuximab-cmkb (Proposed) Trade Name MARGENZA Pharmacologic Class HER2-directed antibody antagonist Code name MGAH22 Applicant MacroGenics, Inc. Formulation(s) 250 mg/10 mL (25 mg/mL) clear to slightly opalescent, colorless to pale yellow or pale brown solution in a single-dose vial Dosing Regimen 15 mg/kg, administered as an intravenous infusion every 3 weeks (21-day cycle) Applicant Proposed Margenza is indicated in patients with HER2+ metastatic breast (b) (4) Indication(s)/Population(s) cancer who have received Recommendation on Approval Regulatory Action Recommended MARGENZA is indicated, in combination with chemotherapy, Indication(s)/Population(s) for the treatment of adult patients with metastatic HER2­ (if applicable) positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. 1 Version date: July 24, 2019 (ALL NDA/ BLA reviews) Disclaimer: In this document, sections labeled as “The Applicant’s Position” are completed by the Applicant and do not necessarily reflect positions of FDA. Reference ID: 4717868 NDA/BLA Multi-disciplinary Review and Evaluation {BLA 761150} {MARGENZA, margetuximab-cmkb} Table of Contents Reviewers of Multi-Disciplinary Review and Evaluation ................................................................ 8 Additional Reviewers of Application ............................................................................................... 9 Glossary ......................................................................................................................................... 10 1 Executive Summary ............................................................................................................... 12 Product Introduction ...................................................................................................... 12 Conclusions on the Substantial Evidence of Effectiveness ............................................ 12 Benefit-Risk Assessment (BRA) ...................................................................................... 14 Patient Experience Data ................................................................................................. 19 2 Therapeutic Context .............................................................................................................. 21 Analysis of Condition ...................................................................................................... 21 Analysis of Current Treatment Options ......................................................................... 22 3 Regulatory Background ......................................................................................................... 29 U.S. Regulatory Actions and Marketing History ............................................................. 29 4 Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety................................................................................................................. 31 Office of Scientific Investigations (OSI) .......................................................................... 31 Product Quality .............................................................................................................. 33 Clinical Microbiology ...................................................................................................... 33 Devices and Companion Diagnostic Issues .................................................................... 34 5 Nonclinical Pharmacology/Toxicology................................................................................... 35 Executive Summary ........................................................................................................ 35 Referenced NDAs, BLAs, DMFs ....................................................................................... 37 Pharmacology ................................................................................................................. 37 ADME/PK ........................................................................................................................ 40 Toxicology ....................................................................................................................... 42 General Toxicology .................................................................................................. 42 Genetic Toxicology .................................................................................................. 45 2 Version date: July 24, 2019 (ALL NDA/ BLA reviews) Disclaimer: In this document, sections labeled as “The Applicant’s Position” are completed by the Applicant and do not necessarily reflect positions of FDA. Reference ID: 4717868 NDA/BLA Multi-disciplinary Review and Evaluation {BLA 761150} {MARGENZA, margetuximab-cmkb} Carcinogenicity ........................................................................................................ 46 Reproductive and Developmental Toxicology ........................................................ 46 Other Toxicology Studies ........................................................................................ 47 6 Clinical Pharmacology ............................................................................................................ 49 Executive Summary ........................................................................................................ 49 Summary of Clinical Pharmacology Assessment ............................................................ 51 Pharmacology and Clinical Pharmacokinetics ........................................................ 51 General Dosing and Therapeutic Individualization ................................................. 52 6.2.2.1. General Dosing ................................................................................................ 52 6.2.2.2. Therapeutic Individualization .......................................................................... 54 6.2.2.3. Outstanding Issues .......................................................................................... 56 Comprehensive Clinical Pharmacology Review ............................................................. 57 General Pharmacology and Pharmacokinetic Characteristics ................................ 57 Clinical Pharmacology Questions ............................................................................ 63 7 Sources of Clinical Data ......................................................................................................... 75 Table of Clinical Studies .................................................................................................. 75 8 Statistical and Clinical Evaluation .......................................................................................... 81 Review of Relevant Individual Trials Used to Support Efficacy ...................................... 81 CP-MGAH22-04 (SOPHIA, Study 04) ....................................................................... 81 Study Results ........................................................................................................... 89 Supportive Study for Efficacy: CP-MGAH22-01 (Study 01) ................................... 112 Integrated Review of Effectiveness ...................................................................... 113 Assessment of Efficacy Across Trials ..................................................................... 114 Integrated Assessment of Effectiveness ............................................................... 114 Review of Safety ........................................................................................................... 117 Safety Review Approach ....................................................................................... 118 Review of the Safety Database ............................................................................. 119 Adequacy of Applicant’s Clinical Safety Assessments .......................................... 123 Safety Results ........................................................................................................ 123 Analysis of Submission-Specific Safety Issues ....................................................... 141 3 Version date: July 24, 2019 (ALL NDA/ BLA reviews) Disclaimer: In this document, sections labeled as “The Applicant’s Position” are completed by the Applicant and do not necessarily reflect positions of FDA. Reference ID: 4717868 NDA/BLA Multi-disciplinary Review and Evaluation {BLA 761150} {MARGENZA, margetuximab-cmkb} Clinical Outcome Assessment (COA) Analyses Informing Safety/Tolerability ...... 144
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