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Clinical Index of Stable Febrile Neutropenia

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81. First- and Second-Generation Antipsychotics in Children and Young Adults: Systematic Review Update

of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted (...) without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders. AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied. This report may

2017 Effective Health Care Program (AHRQ)

82. Sofosbuvir for treating chronic hepatitis C

populations treated with sofosbuvir regimens. Adverse effects of treatment 3.23 The company presented data on adverse events for NEUTRINO, FISSION, FUSION, POSITRON and VALENCE. The most common adverse events among people receiving sofosbuvir and ribavirin therapy (with or without peginterferon alfa) were fatigue, headache, anaemia, nausea, insomnia, irritability, rash, pruritis, myalgia, decreased appetite, influenza-like illness, chills, pyrexia, and neutropenia. Of these events, fatigue and headache (...) ://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 21 of 103sensitivity analysis. Adverse event rates were obtained from the sofosbuvir clinical trials and published studies. The company incorporated the rates of grade 3 and 4 pruritus, diarrhoea and nausea, vomiting, rash, anaemia, thrombocytopenia, neutropenia, and depression from the trials into the model so that drug acquisition costs could be included for interventions associated with managing these adverse events. 3.32 The company used

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

83. Lymphoma

to confirm the diagnosis, provided other morphophenotypic findings are consistent with the diagnosis. Poor prognostic features must be mentioned in the report, including blastoid and pleomorphic morphologic variants. The proliferation index as measured by Ki67 or Mib-1 (used to calculate MIPI score) is to be reported. In cases where it is difficult to differentiate MCL from CLL, flow cytometry for CD200 and IHC for SOX11 may be performed 13 . CLINICAL PRACTICE GUIDELINE LYHE-002 Version 11 I. Diagnosis (...) ) or with local extra-lymphatic extension (IIIE) Stage IV Diffuse involvement of one or more extralymphatic organs or sites ? A: No B symptoms ? B: at least one of the following: unexplained weight loss >10% baseline within 6 months of staging, unexplained fever >38 ° C, or drenching night sweats CLINICAL PRACTICE GUIDELINE LYHE-002 Version 11 II. Staging Page 2 of 3 For treatment planning, patients are divided into two groups by stage: 1. Limited Stage: Non-bulky stage IA(E) or IIA(E) ( 3 or non-adjacent

2016 CPG Infobase

84. Systemic juvenile idiopathic arthritis: canakinumab

was received from the manufacturer. In randomised controlled trials, canakinumab was effective in treating systemic juvenile idiopathic arthritis and allowed children and young people to taper their oral corticosteroid dose. However, risks of treatment include serious infections, neutropenia, leukopenia and thrombocytopenia. Macrophage activation syndrome has also been seen in clinical trials. © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions (...) of the second RCT (n=100), the relative risk reduction in time to flare of systemic juvenile idiopathic arthritis was 64% (hazard ratio 0.36; 95% confidence interval 0.17 to 0.75; p=0.003) with subcutaneous canakinumab 4 mg/kg every 4 weeks compared with placebo. Safety Safety Risks of canakinumab include serious infections, neutropenia, leukopenia, and thrombocytopenia. Macrophage activation syndrome has also been seen in clinical trials of canakinumab in children and young people with systemic juvenile

2014 National Institute for Health and Clinical Excellence - Advice

85. Systemic lupus erythematosus: oral mycophenolate

for up-to-date information. Summary Evidence from a Cochrane review of randomised controlled trials (RCTs) and quasi-RCTs suggests that mycophenolate mofetil is as effective as cyclophosphamide at inducing remission in lupus nephritis, but with a lower risk of ovarian failure. For maintenance therapy in lupus nephritis the Cochrane review found that mycophenolate mofetil was more effective than azathioprine for preventing relapse, with no increase in clinically important adverse events. Data in non (...) infections that can be fatal, sepsis and neutropenia. Mycophenolate has also been associated with pure red cell aplasia and serious gastrointestinal adverse events (Cellcept, Roche and Myfortic, Novartis summaries of product characteristics). P Patient factors atient factors For induction therapy in lupus nephritis, mycophenolate mofetil was found to be associated with a lower risk of toxic adverse events such as ovarian failure, alopecia and leucopenia, compared with cyclophosphamide. Reduced risk

2014 National Institute for Health and Clinical Excellence - Advice

86. Palbociclib (Ibrance) - locally advanced or metastatic breast cancer

Evaluation Criteria in Solid Tumors RH Relative Humidity RP2D recommended Phase 2 dose RP-HPLC Reversed-phase high performance liquid chromatography RR time from the peak of 1 QRS complex to the peak of the next as shown on the electrocardiogram SAE serious adverse event SAP Statistical Analysis Plan SCE Summary of Clinical Efficacy SCP Summary of Clinical Pharmacology Studies SCS Summary of Clinical Safety sCSR Supplemental Clinical Study Report SD stable disease sec second SOC system organ class Std (...) for toxicology and clinical studies through Phase 2. However, its physical properties were deemed unsuitable for commercial development. Therefore, the free base of palbociclib, which was found to have excellent physical and chemical stability, was selected for commercial use. Palbociclib exhibits polymorphism. The crystalline anhydrous Form A of palbociclib free base is the thermodynamically more stable form within the temperature ranges that are relevant to manufacturing and storage conditions

2016 European Medicines Agency - EPARs

87. Oncaspar - pegaspargase

14 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 16 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 16 2.2.6. Recommendations for future quality development 16 2.3. Non-clinical aspects 16 2.3.1. Introduction 16 2.3.2. Pharmacology 17 2.3.3. Pharmacokinetics 20 2.3.4. Toxicology 25 2.3.5. Ecotoxicity/environmental risk assessment 31 2.3.6. Discussion on non-clinical aspects 31 2.3.7. Conclusion on the non-clinical aspects 34 2.4. Clinical aspects (...) 34 2.4.1. Introduction 34 2.4.2. Pharmacokinetics 37 2.4.3. Pharmacodynamics 53 2.4.4. Discussion on clinical pharmacology 56 2.4.5. Conclusions on clinical pharmacology 59 2.5. Clinical efficacy 59 2.5.1. Dose response studies 59 2.5.2. Main studies 60 2.5.3. Discussion on clinical efficacy 93 2.5.4. Conclusions on the clinical efficacy 96 2.6. Clinical safety 96 2.6.1. Discussion on clinical safety 109 2.6.2. Conclusions on the clinical safety 115 2.7. Pharmacovigilance 115 2.8. Risk Management

2016 European Medicines Agency - EPARs

88. Portrazza - necitumumab

parameters, well justified and supported by appropriate data. The acceptance criteria proposed in the testing of the active substance and the finished product has been justified based on experience from clinical trials. In most cases the limits are not exactly covered by clinical experience but the small deviation is not considered to have a significant impact on safety and efficacy. The stability results indicate that the active substance and finished product are sufficiently stable and justify (...) Product 15 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 28 2.3.4. Toxicology 30 2.3.5. Ecotoxicity/environmental risk assessment 33 2.3.6. Discussion on non-clinical aspects 33 2.3.7. Conclusion on the non-clinical aspects 34 2.4. Clinical aspects

2016 European Medicines Agency - EPARs

89. Neofordex - dexamethasone. To treat adults with multiple myeloma

2.2.2. Finished medicinal product 11 2.2.3. Discussion on chemical, and pharmaceutical aspects 14 2.2.4. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.5. Recommendation for future quality development 15 2.3. Non-clinical aspects 15 2.3.1. Introduction 15 2.3.2. Pharmacology 15 2.3.3. Pharmacokinetics 18 2.3.4. Toxicology 21 2.3.5. Ecotoxicity/environmental risk assessment 25 2.3.6. Discussion on non-clinical aspects 25 2.3.7. Conclusion on the non-clinical aspects 26 2.4 (...) . Clinical aspects 26 2.4.1. Introduction 26 2.4.2. Pharmacokinetics 27 2.4.3. Pharmacodynamics 32 2.4.4. Clinical efficacy 32 2.4.5. Clinical safety 45 2.4.6. Discussion on clinical aspects 46 2.4.7. Conclusions on clinical aspects 48 2.5. Pharmacovigilance 48 2.6. Product information 52 2.6.1. User consultation 52 3. Benefit-risk balance 52 4. Recommendation 53 Divergent Position 59 Assessment report EMA/CHMP/6613/2016 Page 3/61 List of abbreviations AE Adverse Event ASCT Autologous Stem Cell

2016 European Medicines Agency - EPARs

90. Ixazomib (Ninlaro) - multiple myeloma

. Introduction 10 2.2.2. Active Substance 10 2.2.3. Finished Medicinal Product 13 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 16 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 17 2.2.6. Recommendation(s) for future quality development 17 2.3. Non-clinical aspects 17 2.3.1. Introduction 17 2.3.2. Pharmacology 17 2.3.3. Pharmacokinetics 26 2.3.4. Toxicology 33 2.3.5. Ecotoxicity/environmental risk assessment 48 2.3.6. Discussion on non-clinical aspects 48 (...) 2.3.7. Conclusion on the non-clinical aspects 50 2.4. Clinical aspects 50 2.4.1. Introduction 50 2.4.2. Pharmacokinetics 52 2.4.3. Pharmacodynamics 63 2.4.4. Discussion on clinical pharmacology 65 2.4.5. Conclusions on clinical pharmacology 67 2.5. Clinical efficacy 68 2.5.1. Dose response studies 68 2.5.2. Main study 71 2.5.3. Discussion on clinical efficacy 99 2.5.4. Conclusions on the clinical efficacy 102 2.6. Clinical safety 102 2.6.1. Discussion on clinical safety 115 2.6.2. Conclusions

2016 European Medicines Agency - EPARs

91. Onivyde - metastatic adenocarcinoma of the pancreas

under the plasma concentration time curve BMI Body Mass Index BSA Body Surface Area CA 19-9 Carbohydrate antigen 19-9 CBR Clinical Benefit Response CEP Certificate of Suitability of the EP CHMP Committee for Medicinal Products for Human use CI Confidence Interval CL Clearance Cmax Maximum plasma concentration Cmin Minimum plasma concentration CR Complete Response CSR Clinical Study Report CTCAE Common Terminology Criteria for Adverse Events CYP3A4 Cytochrome P450 3A4 dL Deciliter DMSO Dimethyl (...) four patients had DLTs (i.e, grade 4 leucopenia and neutropenia lasting for longer than 3 days; grade 3 febrile neutropenia and grade 3 diarrhoea). The dose was then reduced (120 mg/m 2 ), and 1 patient among a total of 6 treated at this dose level experienced a DLT (Grade 3 infection). Therefore, based on these results 120 mg/m 2 was determined as MTD for MM-398 single agent (see further details in Section 2.1.3). Overall, 2 patients with advanced pancreatic cancer patients, both treated at 180 mg

2016 European Medicines Agency - EPARs

92. Crohn's disease: management

) should only be continued if there is clear evidence of ongoing active disease as determined by clinical symptoms, biological markers and investigation, including endoscopy if necessary. Specialists should discuss the risks and benefits of continued treatment with patients and consider a trial withdrawal from treatment for all patients who are in stable clinical remission. People who continue treatment with infliximab or adalimumab should have their disease reassessed at least every 12 months (...) frequent (3–4 or more) diarrhoeal stools daily. People with severe active Crohn's disease may or may not develop new fistulae or have extra-intestinal manifestations of the disease. This clinical definition normally, but not exclusively, corresponds to a Crohn's Disease Activity Index (CDAI) score of 300 or more, or a Harvey-Bradshaw score of 8 to 9 or above. [2012] [2012] 1.2.19 When using the CDAI and Harvey-Bradshaw Index, healthcare professionals should take into account any physical, sensory

2012 National Institute for Health and Clinical Excellence - Clinical Guidelines

93. Kyprolis - carfilzomib

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

2015 European Medicines Agency - EPARs

94. Lynparza - olaparib

and biological aspects 20 2.2.1. Conclusions on the chemical, pharmaceutical and biological aspects 21 2.2.2. Recommendation(s) for future quality development 21 2.3. Non-clinical aspects 21 2.3.1. Introduction 21 2.3.2. Pharmacology 22 2.3.3. Pharmacokinetics 26 2.3.4. Toxicology 33 2.3.5. Ecotoxicity/environmental risk assessment 41 2.3.6. Discussion on non-clinical aspects 43 2.3.7. Conclusion on the non-clinical aspects 48 2.4. Clinical aspects 48 2.4.1. Introduction 48 2.4.2. Pharmacokinetics 52 2.4.3 (...) . Pharmacodynamics 64 2.4.4. Discussion on clinical pharmacology 68 2.4.5. Conclusions on clinical pharmacology 75 2.5. Clinical efficacy 76 2.5.1. Dose response studies 76 2.5.2. Main studies 78 2.5.3. Discussion on clinical efficacy 126 2.5.4. Conclusions on the clinical efficacy 131 2.6. Clinical safety 131 2.6.1. Discussion on clinical safety 163 2.6.2. Conclusions on the clinical safety 169 2.7. Pharmacovigilance 170 2.8. Risk Management Plan 170 2.9. Product information 183 2.9.1. User consultation 183

2015 European Medicines Agency - EPARs

95. Farydak - panobinostat

and biological aspects 17 2.2.6. Recommendations for future quality development 17 2.3. Non-clinical aspects 17 2.3.1. Introduction 17 2.3.2. Pharmacology 17 2.3.4. Toxicology 28 2.3.5. Ecotoxicity/environmental risk assessment 39 2.3.6. Discussion on non-clinical aspects 40 2.3.7. Conclusion on the non-clinical aspects 42 2.4. Clinical aspects 42 2.4.1. Introduction 42 2.4.2. Pharmacokinetics 43 2.4.3. Pharmacodynamics 49 2.4.4. Discussion on clinical pharmacology 50 2.4.5. Conclusions on clinical (...) pharmacology 53 2.5. Clinical efficacy 54 2.5.1. Dose response study 54 2.5.2. Main study 56 2.5.3. Discussion on clinical efficacy 84 2.5.4. Conclusions on the clinical efficacy 88 2.6. Clinical safety 89 2.6.1. Discussion on clinical safety 102 2.6.2. Conclusions on the clinical safety 107 2.7. Pharmacovigilance 107 2.8. Risk Management Plan 107 2.9. Product information 118 2.9.1. User consultation 118 Assessment report EMA/CHMP/496296/2015 Page 2/124 3. Benefit-Risk Balance 118 4. Recommendations 121

2015 European Medicines Agency - EPARs

96. Cosentyx - secukinumab

CCV cardiovascular/cerebrovascular CHO Chinese hamster ovary Cmax maximum serum concentration after a single dose CMH Cochran-Mantel-Haenszel CRF case report/record form CSR clinical study report CTCAE Common Terminology Criteria for Adverse Events CYP cytochrome DDI drug-drug interaction DILI drug-induced liver injury DLQI Dermatology Life Quality Index dPGA dynamic Physician’s Global Assessment ECG electrocardiogram EQ-5D EuroQOL 5-Dimension Health Questionnaire © EMA European Medicines Agency (...) FAS Full Analysis Set FDA United States Food and Drug Administration FI fixed interval dosing GCP Good Clinical Practice GGT gamma-glutamyltransferase HA health authority HAQ-DI Health Assessment Questionnaire©-Disability Index HRQoL health-related quality of life hBD-2 human beta defensin-2 HLT high level term hsCRP high sensitivity C-reactive protein IBD inflammatory bowel disease IGA Investigator’s Global Assessment IGA mod 2007 IGA scale used in part of the phase II program, 6-point scale IGA

2015 European Medicines Agency - EPARs

97. Sivextro - tedizolid phosphate

to Hour 24.I BCRP breast cancer resistance protein BMI body mass index CA-MRSA community-acquired methicillin-resistant Staphylococcus aureus CDAD Clostridium difficile associated disease CE Clinically Evaluable CE-PTE Clinically Evaluable at PTE Cfr chloramphenicol-florfenicol resistance CFU/g CHMP log 10 Committee for Medicinal Products for Human Use CI confidence interval CL clearance CL/F apparent clearance CLSI Clinical and Laboratory Standards Institute cMITT Clinical modified ITT CQAs cSSTI (...) product is physically and chemically stable for up to 24 hours when reconstituted with WFI, and stored under the above-mentioned conditions. Compatibility of the drug product reconstituted with 0.9% aqueous NaCl solution in IV bags was studied in combination with different IV administration sets that represent those typically found in the clinical setting. Reconstituted solutions were evaluated for up to 24 hours under both room temperature and refrigerated conditions. All samples were tested

2015 European Medicines Agency - EPARs

98. Daclatasvir (DCV) (Daklinza)

Daclatasvir (DCV) (Daklinza) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 206843Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Resubmission Application Number(s) 206-843 Priority or Standard N/A Submit Date(s) February 13, 2015 Received Date(s) February 13, 2015 PDUFA Goal Date August 13, 2015 Division / Office DAVP/OAP Reviewer Name(s) Wendy Carter, D.O. Review Completion Date June 29, 2015 Established Name Daclatasvir (DCV) (Proposed) Trade Name Daklinza (...) 12 2.4 Important Safety Issues With Consideration to Related Drugs 12 2.5 Summary of Presubmission Regulatory Activity Related to Submission 12 2.6 Other Relevant Background Information 13 3 ETHICS AND GOOD CLINICAL PRACTICES 13 3.1 Submission Quality and Integrity 13 3.2 Compliance with Good Clinical Practices 13 3.3 Financial Disclosures 13 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES 14 4.1 Chemistry Manufacturing and Controls 14 4.2 Clinical Microbiology 14 4.3

2015 FDA - Drug Approval Package

99. Addyi - Flibanserin

clinical practice are unknown. Estimates of the prevalence of HSDD in U.S. women vary widely, depending on the instruments used for assessment as well as menopausal status of the women studied. Two large survey studies have estimated the prevalence of HSDD in U.S. premenopausal women to be 7.7% to 14%, 2,3 potentially affecting 5.5 to 8.6 million U.S. women ages 20 to 49. However, methodological limitations inherent in these surveys, such as recall bias and low response rates (4.8% and 8.2 (...) %, respectively in West and Lieblum, et al.), makes it difficult to estimate the prevalence of HSDD in the U.S. There are no FDA approved pharmacotherapies to treat HSDD in either women or men. While psychological interventions – such as cognitive behavior therapy, sex therapy, or couples therapies – have been shown to decrease symptom severity in women with HSDD, 4 evidence from large, place-controlled clinical trials demonstrating effectiveness of psychological therapies is lacking. Testosterone has been

2015 FDA - Drug Approval Package

100. Cariprazine HCl (Vraylar)

Cariprazine HCl (Vraylar) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204370Orig1Orig2s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type CR response 2 nd cycle Application Number(s) 204370/067 Priority or Standard standard Submit Date(s) December17, 2014 Received Date(s) 12/17/2014 PDUFA Goal Date 6/17/2015 Division / Office DPP/ODE1 Reviewer Name(s) Lucas Kempf, MD Review Completion Date September 15, 2015 Established Name Cariprazine HCl (Proposed) Trade Name Vraylar (...) Therapeutic Class Antipsychotic Applicant Forest Laboratories, LLC. Formulation(s) capsules 1.5 mg, 3 mg, 4.5 mg, and 6 mg Dosing Regimen daily Indication(s) schizophrenia and acute Bipolar Manic episode Intended Population(s) Adult patients with schizophrenia and Bipolar Reference ID: 3820323 (b) (4)Template Version: March 6, 2009 Reference ID: 3820323NDA 204370 Clinical Review Lucas Kempf, MD Resubmission 2 nd cycle Vraylar, Cariprazine HCl 3 Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT 7

2015 FDA - Drug Approval Package

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