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Assessment Report 24 September 2015 EMA/670306/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Kyprolis International non-proprietary name: Carfilzomib Procedure No. EMEA/H/C/003790/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact An agency of the European Union Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ..................................................................................... 7 1.2. Steps taken for the assessment of the product ........................................................ 8 2. Scientific discussion ................................................................................ 9 2.1. Introduction ........................................................................................................ 9 2.2. Quality aspects .................................................................................................. 10 2.2.1. Introduction.................................................................................................... 10 2.2.2. Active Substance ............................................................................................. 11 2.2.3. Finished Medicinal Product ................................................................................ 13 2.2.4. Discussion on chemical, pharmaceutical and biological aspects.............................. 18 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects ...................... 18 2.2.6. Recommendation for future quality development ................................................. 18 2.3. Non-clinical aspects ............................................................................................ 19 2.3.1. Introduction.................................................................................................... 19 2.3.2. Pharmacology ................................................................................................. 19 2.3.3. Pharmacokinetics ............................................................................................ 23 2.3.4. Toxicology ...................................................................................................... 24 2.3.5. Ecotoxicity/environmental risk assessment ......................................................... 31 2.3.6. Discussion on non-clinical aspects ..................................................................... 32 2.3.7. Conclusion on the non-clinical aspects ............................................................... 35 2.4. Clinical aspects .................................................................................................. 35 2.4.1. Introduction.................................................................................................... 35 2.4.2. Pharmacokinetics ............................................................................................ 35 2.4.3. Pharmacodynamics .......................................................................................... 41 2.4.4. Discussion on clinical pharmacology ................................................................... 44 2.4.5. Conclusions on clinical pharmacology ................................................................. 46 2.5. Clinical efficacy .................................................................................................. 46 2.5.1. Dose response studies ..................................................................................... 46 2.5.2. Main study ..................................................................................................... 47 2.5.3. Discussion on clinical efficacy ............................................................................ 86 2.5.4. Conclusions on the clinical efficacy .................................................................... 88 2.6. Clinical safety .................................................................................................... 88 2.6.1. Discussion on clinical safety ............................................................................ 121 2.6.2. Conclusions on the clinical safety .................................................................... 127 2.7. Risk Management Plan ...................................................................................... 127 2.8. Pharmacovigilance ........................................................................................... 134 2.9. Product information .......................................................................................... 135 2.9.1. User consultation .......................................................................................... 135 2.9.2. Additional monitoring ..................................................................................... 135 Assessment report EMA/670306/2015 Page 2/142 3. Benefit-Risk Balance ........................................................................... 135 4. Recommendations ............................................................................... 139 Assessment report EMA/670306/2015 Page 3/142 List of abbreviations ADR adverse drug reaction AE adverse event ALT alanine aminotransferase ANC absolute neutrophil count AS Active substance ASM Active Substance Manufacturer AST aspartate aminotransferase AUC area under the plasma curve AV atrioventricular BCS Biopharmaceutics Classification System BSA body surface area CBR clinical benefit rate CD cyclodextrin CFU Colony Forming Units CHMP Committee for Medicinal Products for Human use CI confidence interval C-L caspase-like CL clearance Cmax maximum concentration CPP Critical process parameter CQA Critical Quality Attribute CR complete response CRP C-reactive protein CSR clinical study report CT-L chymotrypsin-like CYP3A4/5 cytochrome P450 3A4/5 D high-dose dexamethasone (40 mg PO on Days 1–4, 9–12, and 17–20 of each 28-day cycle) d low-dose dexamethasone (40 mg PO on Days 1, 8, 15, and 22 of each 28-day cycle) DCR disease control rate DLT dose limiting toxicity DMC Data Monitoring Committee DoE Design of experiments DOR duration of response DOX/Doxil liposomal doxorubicin DSC Differential Scanning Calorimetry EBMT European Group for Blood and Marrow Transplantation EC Ethics Committee EC European Commission ECG electrocardiogram EMA European Medicines Agency EORTC European Organization for Research and Treatment of Cancer EP European Pharmacopoeia ESMO European Society for Medical Oncology EU European Union EWP Efficacy Working Party FDA Food and Drug Administration GC(-MS) Gas Chromatography (-mass spectrometry) GCP Good Clinical Practice GI gastrointestinal GMP Good Manufacturing Practice HDPE High Density Polyethylene HPCD hydroxypropyl beta-cyclodextrin HPLC -PDA) High performance liquid chromatography (photo diode array) HR hazard ratio Assessment report EMA/670306/2015 Page 4/142 HRQL health-related quality of life HtrA2 pro-survival protease in neurons HUS hemolytic uremic syndrome IBD international birth date ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICP-OES Inductively coupled plasma optical emission spectrometry IDMC Independent Data Monitoring Committee IMiD immunomodulatory drug IMWG International Multiple Myeloma Working Group IPC In-process control IR Infrared IRC Independent Review Committee ISS International Staging System IU International Units IV intravenous K-M Kaplan-Meier KRd Kyprolis (carfilzomib), Revlimid (lenalidomide), and low-dose dexamethasone LC-MS Liquid chromatography mass spectrometry LDPE Low density polyethylene LoD Limit of Detection LOQ Limit of Quantitation MAA Marketing Authorisation Application MDD maximum daily dose MECL1 multicatalytic endopeptidase complex-like 1 MedDRA Medical Dictionary for Regulatory Activities mg milligram MI myocardial infarction ml or mL millilitre MM multiple myeloma MMRM mixed model for repeated measures MPD maximum planned dose M-protein monoclonal protein MS Mass Spectrometry MTD maximum tolerated dose NA not applicable OR not available ND Not detected NE not estimable NMR Nuclear Magnetic Resonance NR not reported OR non-response NYHA New York Heart Association ONX Onyx defined grouping OR specified search strategy ORCA Onyx Response Computation Assessment ORR overall response rate OS overall survival PAR Proven Acceptable Range PD progressive disease PE Polyethylene PFS progression-free survival P-gp P-glycoprotein Ph. Eur. European Pharmacopoeia PI Prescribing Information PIL Patient Information Leaflet PK pharmacokinetic PR partial response PRES posterior reversible encephalopathy syndrome PT preferred term QbD Quality by design QC Quality Control Assessment report EMA/670306/2015 Page 5/142 QLQ-C30 Quality of Life Questionnaire Core Module QLQ-MY20 Quality of Life Questionnaire for Multiple Myeloma QoL Quality of Life QOS Quality Overall Summary QP Qualified person QRS measured from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization QTc corrected QT interval QTcF corrected QT (interval) Fridericia’s correction QTc-PK corrected QT interval-pharmacokinetic QTPP Quality target product profile QWP Quality Working Party R Revlimid (lenalidomide) R/R relapsed/refractory
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