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761097Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 761097Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA/BLA Multi-disciplinary Review and Evaluation {BLA 761097} {Libtayo™/cemiplimab} NDA/BLA Multi-Disciplinary Review and Evaluation Application Type NME Application Number(s) BLA 761097 Priority or Standard Priority Submit Date(s) February 28, 2018 Received Date(s) February 28, 2018 PDUFA Goal Date October 28, 2018 Division/Office DOP2/OHOP Established Name Cemiplimab-rwlc (Cemiplimab) (Proposed) Trade Name LIBTAYO™ Pharmacologic Class PD-1 blocking antibody Code name REGN2810 Applicant Regeneron Pharmaceuticals, Inc. Formulation(s) Injection: 350 mg/7 mL (50 mg/mL) solution in a single-dose vial Dosing Regimen 350 mg as an intravenous infusion over 30 minutes every 3 weeks Applicant Proposed Treatment of patients with metastatic cutaneous squamous cell Indication(s)/Population(s) carcinoma or patients with locally advanced cutaneous squamous cell carcinoma who are not candidates for surgery Recommendation on Approval Regulatory Action LIBTAYO is indicated for the treatment of patients with Recommended metastatic cutaneous squamous cell carcinoma (CSCC) or Indication(s)/Population(s) locally advanced CSCC who are not candidates for curative surgery or curative radiation 1 Version date: February 1, 2016 for initial rollout (NME/original BLA reviews) Reference ID: 4324348 NDA/BLA Multi-disciplinary Review and Evaluation {BLA 761097} {Libtayo™/cemiplimab} Table of Contents Reviewers of Multi-Disciplinary Review and Evaluation.................................................................8 Additional Reviewers of Application ..............................................................................................8 Glossary ..........................................................................................................................................9 1 Executive Summary...............................................................................................................11 1.1. Product Introduction......................................................................................................11 1.2. Conclusions on the Substantial Evidence of Effectiveness.............................................11 1.3. Benefit-Risk Assessment ................................................................................................14 1.4. Patient Experience Data.................................................................................................17 2 Therapeutic Context..............................................................................................................19 2.1. Analysis of Condition......................................................................................................19 2.2. Analysis of Current Treatment Options .........................................................................19 3 Regulatory Background .........................................................................................................22 3.1. U.S. Regulatory Actions and Marketing History.............................................................22 3.2. Summary of Presubmission/Submission Regulatory Activity ........................................22 4 Significant Issues from Other Review Disciplines Pertinent to Clinical Conclusions on Efficacy and Safety ................................................................................................................26 4.1. Office of Scientific Investigations (OSI) ..........................................................................26 4.2. Product Quality ..............................................................................................................26 4.3. Clinical Microbiology......................................................................................................26 4.4. Devices and Companion Diagnostic Issues ....................................................................26 5 Nonclinical Pharmacology/Toxicology ..................................................................................27 5.1. Executive Summary........................................................................................................27 5.2. Referenced NDAs, BLAs, DMFs ......................................................................................30 5.3. Pharmacology ................................................................................................................30 5.4. ADME/PK........................................................................................................................36 5.5. Toxicology ......................................................................................................................36 5.5.1. General Toxicology .................................................................................................36 5.5.2. Genetic Toxicology..................................................................................................41 5.5.3. Carcinogenicity .......................................................................................................41 2 Version date: February 1, 2016 for initial rollout (NME/original BLA reviews) Reference ID: 4324348 NDA/BLA Multi-disciplinary Review and Evaluation {BLA 761097} {Libtayo™/cemiplimab} 5.5.4. Reproductive and Developmental Toxicology ........................................................41 5.5.5. Other Toxicology Studies ........................................................................................45 6 Clinical Pharmacology ...........................................................................................................47 6.1. Executive Summary........................................................................................................47 6.2. Summary of Clinical Pharmacology Assessment............................................................47 6.2.1. Pharmacology and Clinical Pharmacokinetics.........................................................48 6.2.2. General Dosing and Therapeutic Individualization.................................................49 6.3. Comprehensive Clinical Pharmacology Review..............................................................49 6.3.1. General Pharmacology and Pharmacokinetic Characteristics ................................49 6.3.2. Clinical Pharmacology Questions............................................................................51 7 Sources of Clinical Data and Review Strategy .......................................................................62 7.1. Table of Clinical Studies .................................................................................................62 7.2. Review Strategy .............................................................................................................64 8 Statistical and Clinical and Evaluation...................................................................................65 8.1. Review of Relevant Individual Trials Used to Support Efficacy ......................................65 8.1.1. Studies R2810-ONC-1423 and R2810-ONC-1540....................................................65 8.1.2. Study Results ..........................................................................................................68 8.1.3. Integrated Assessment of Effectiveness.................................................................87 8.2. Review of Safety.............................................................................................................87 8.2.1. Safety Review Approach .........................................................................................87 8.2.2. Review of the Safety Database ...............................................................................88 8.2.3. Adequacy of Applicant’s Clinical Safety Assessments.............................................90 8.2.4. Safety Results..........................................................................................................91 8.2.5. Analysis of Submission-Specific Safety Issues.......................................................110 8.2.6. Clinical Outcome Assessment (COA) Analyses Informing Safety/Tolerability ......126 8.2.7. Safety Analyses by Demographic Subgroups........................................................126 8.2.8. Specific Safety Studies/Clinical Trials....................................................................127 8.2.9. Additional Safety Explorations..............................................................................127 8.2.10. Safety in the Postmarket Setting...................................................................127 8.2.11. Integrated Assessment of Safety...................................................................129 SUMMARY AND CONCLUSIONS..................................................................................................130 3 Version date: February 1, 2016 for initial rollout (NME/original BLA reviews) Reference ID: 4324348 NDA/BLA Multi-disciplinary Review and Evaluation {BLA 761097} {Libtayo™/cemiplimab} 8.3. Statistical Issues ...........................................................................................................130 8.4. Conclusions and Recommendations ............................................................................130 9 Advisory Committee Meeting and Other External Consultations .......................................133
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