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Clinical Index of Stable Febrile Neutropenia

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61. Rituximab (Ritemvia) - follicular lymphoma and diffuse large B cell non-Hodgkin?s lymphoma OR granulomatosis with polyangiitis (GPA or Wegener?s granulomatosis) and microscopic polyangiitis (MPA)

ESR Fc gamma receptor R1 (CD64) Erythrocyte sedimentation rate Assessment report EMA/CHMP/421799/2017 Page 5/160 Fc?RIIIa-V EULAR Fc gamma receptor 3a (CD16a) V type receptor European league against rheumatism FcRn GCP neonatal Fc receptor Good clinical practice GI Gastrointestinal GMP GPA Good Manufacturing Practice Granulomatosis with polyangiitis HACA Human anti-chimeric antibodies HAQ Health assessment questionnaire disability index HBV Hepatitis B virus HCP HMW Host Cell Protein Higher (...) Substance 13 2.1.3. Finished Medicinal Product 16 2.1.4. Discussion on chemical, pharmaceutical and biological aspects 20 2.1.5. Conclusions on the chemical, pharmaceutical and biological aspects 20 2.1.6. Recommendation(s) for future quality development 20 2.2. Non-clinical aspects 20 2.2.1. Introduction 20 2.2.2. Pharmacology 21 2.2.3. Pharmacokinetics 26 2.2.4. Toxicology 27 2.2.5. Ecotoxicity/environmental risk assessment 29 2.2.6. Discussion on non-clinical aspects 30 2.2.7. Conclusion on the non

2017 European Medicines Agency - EPARs

62. Rituximab (Rituzena (previously Tuxella)) - follicular lymphoma and diffuse large B cell non-Hodgkin?s lymphoma OR chronic lymphocytic leukaemia OR granulomatosis with polyangiitis (GPA or Wegener?s granulomatosis) and microscopic polyangiitis (MPA)

under the serum concentration-time curve from the start of the first infusion to the last measurable concentration after the second infusion AUC0-t Area under the serum concentration-time curve from the start of first infusion to start of the second infusion AUCt-8 Area under the serum concentration-time curve from the start of second infusion to infinity BA Bioavailability BE Bioequivalence CCP Cyclic citrullinated protein CD CDAI Circular dichroism Clinical disease activity index CDC Complement (...) (CD64) Erythrocyte sedimentation rate Assessment report EMA/CHMP/421811/2017 Page 5/160 Fc?RIIIa-V EULAR Fc gamma receptor 3a (CD16a) V type receptor European league against rheumatism FcRn GCP neonatal Fc receptor Good clinical practice GI Gastrointestinal GMP GPA Good Manufacturing Practice Granulomatosis with polyangiitis HACA Human anti-chimeric antibodies HAQ Health assessment questionnaire disability index HBV Hepatitis B virus HCP HMW Host Cell Protein Higher Molecular Weight ICH Ig

2017 European Medicines Agency - EPARs

63. Ribociclib (Kisqali) - breast cancer

with all information of a commercially confidential nature deleted. Assessment report EMA/CHMP/506968/2017 Page 2/121 Table of contents 1. Background information on the procedure 6 1.1. Submission of the dossier 6 1.2. Steps taken for the assessment of the product 7 2. Scientific discussion 7 2.1. Problem statement 7 2.1.1. Disease or condition 7 2.1.2. Epidemiology 8 2.1.3. Biologic features 8 2.1.4. Clinical presentation, diagnosis and stage/prognosis 8 2.1.5. Management 8 2.2. Quality aspects 10 (...) 2.2.1. Introduction 10 2.2.2. Active Substance 10 2.2.3. Finished Medicinal Product 12 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 14 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.6. Recommendations 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 17 2.3.4. Toxicology 19 2.3.5. Ecotoxicity/environmental risk assessment 24 2.3.6. Discussion on non-clinical

2017 European Medicines Agency - EPARs

64. Niraparib (Zejula) - Fallopian Tube Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms

Administration FE food effect FIGO Fédération Internationale de Gynécologie et d’Obstétrique FOSI Functional Assessment of Cancer Therapy – Ovarian Symptom Index FT-IR Fourier Transform Infrared Spectroscopy gBRCAmut germline BRCA mutation GC Gas Chromatography GCP goof clinical practise HDPE High Density Polyethylene hERG human Ether-a-go-go-related gene HMHDPE High Molecular Weight High Density Polyethylene HPLC High performance liquid chromatography HR hazard ratio HRD homologous recombination deficient (...) Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/648982/2017 Page 2/122 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. Problem statement 9 2.1.1. Disease or condition 9 2.1.2. Epidemiology 9 2.1.3. Biologic features 9 2.1.4. Clinical presentation, diagnosis and stage/prognosis 9

2017 European Medicines Agency - EPARs

65. Chimeric Antigen Receptor T-Cell Therapy for B-Cell Cancers: Effectiveness and Value

stimulating factors for primary prevention of febrile neutropenia in patients whose risk for this complication is less than 20%. Comparative Clinical Effectiveness The comparative clinical effectiveness review of the CAR-T therapies with other salvage therapies for ALL or DLBCL was challenged because all of the clinical studies were small, single-arm designs with limited follow-up and incomplete reporting. Since no trials had control groups, it was not possible to estimate the comparative benefits (...) are summarized in Table ES9 below. 34 ©Institute for Clinical and Economic Review, 2018 Page ES13 Evidence Report – CAR-T Therapies for B-Cell Cancers Return to Table of Contents Table ES9. Key Adverse Events in the ZUMA-1 Trial (n=101) Adverse Event All Grades Grade 3 or Higher Cytokine Release Syndrome 94% 13% Neurologic Toxicities 87% 31% Fever 86% 16% Encephalopathy 57% 29% Headache 45% 1% Renal Insufficiency 12% 5% Hypotension 57% 15% Hypoxia 32% 11% Infections – Pathogens Unknown 26% 16% Viral

2018 California Technology Assessment Forum

66. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Full Text available with Trip Pro

, such as acute generalized exanthematous pusulosis. Consider following patients closely using serial clinical photography. If mucous membrane involvement or blistering is observed on the skin, consider early admission to a burn center for further monitoring and management. Primer on monitoring for complicated cutaneous adverse drug reactions: ○ Review of systems: skin pain (“like a sunburn”), fevers, malaise, myalgias, arthralgias, abdominal pain, ocular discomfort or photophobia, sores or discomfort (...) Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline | Journal of Clinical Oncology Search in: Menu Article Tools ASCO SPECIAL ARTICLE Article Tools OPTIONS & TOOLS COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2017.77.6385 Journal of Clinical

2018 American Society of Clinical Oncology Guidelines

67. Dinutuximab beta (Qarziba) - neuroblastoma

chemotherapy, surgery, myeloablative chemotherapy and radiotherapy. It is prolonged, intensive, debilitating and associated with substantial adverse events, some of which are potentially life-threatening. Adverse events can include frequent vomiting, hair loss, weight loss, pain, fever and neutropenia that may progress to sepsis and death. There may also be long-term effects for survivors, including hearing loss, organ dysfunction, sterility, growth and development issues and secondary malignancies. 4 (...) survival (EFS) or stable disease health state, failure state, and death. Patients enter the model in the EFS state and start treatment with dinutuximab beta plus isotretinoin or isotretinoin alone for a maximum of 5 cycles. Patients were aged 3.7 years and 6.1 years in the high-risk and R/R models respectively based on the mean ages in the relevant studies. For the high-risk subgroup, the source of the clinical data was the MAIC described above which used data from the APN311-302 study

2018 Scottish Medicines Consortium

68. Dinutuximab beta Apeiron - neuroblastoma

. Epidemiology 11 2.1.3. Biologic features 11 2.1.4. Clinical presentation, diagnosis and stage/prognosis 11 2.1.5. Management 12 2.2. Quality aspects 15 2.2.1. Introduction 15 2.2.2. Active Substance 16 2.2.3. Finished Medicinal Product 26 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 31 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 33 2.2.6. Recommendations for future quality development 34 2.3. Non-clinical aspects 34 2.3.1. Introduction 34 2.3.2 (...) . Pharmacology 34 2.3.3. Pharmacokinetics 37 2.3.4. Toxicology 39 2.3.5. Ecotoxicity/environmental risk assessment 41 2.3.6. Discussion on non-clinical aspects 41 2.3.7. Conclusion on the non-clinical aspects 43 2.4. Clinical aspects 43 2.4.1. Introduction 43 2.4.2. Pharmacokinetics 44 2.4.3. Pharmacodynamics 47 2.4.4. Discussion on clinical pharmacology 49 2.4.5. Conclusions on clinical pharmacology 52 2.5. Clinical efficacy 52 2.5.1. Dose response studies and main clinical studies 52 2.5.2. Discussion

2017 European Medicines Agency - EPARs

69. Comprehensive Systematic Review Summary: Disease-modifying Therapies for Adults with Multiple Sclerosis

, DO 7 ; June Halper, MSN, APN-C, MSCN 8 ; Jonathan P. Hosey, MD 9 ; David E. Jones, MD 10 ; Robert Lisak, MD 11 ; Daniel Pelletier, MD 12 ; Sonja Potrebic, MD, PhD 13 ; Cynthia Sitcov 14 ; Rick Sommers, LMSW 15 ; Julie Stachowiak, PhD 16 ; Thomas S.D. Getchius 17 ; Shannon A. Merillat, MLIS 18 ; Tamara Pringsheim, MD, MSc 19 1. Department of Neurology, Cleveland Clinic, OH 2. Department of Neurology, Charles F. and Joanne Knight Alzheimer Disease Research Center, Washington University in St. Louis (...) , MO 3. Departments of Medicine and Community Health Sciences, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada 4. Department of Neurology, Mayo Clinic, Rochester, MN 5. UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco 6. Department of Neurology, Kansas University Medical Center, Kansas City 7. Department of Neurology, School of Medicine, University of Louisville, KY 8. Consortium

2018 American Academy of Neurology

70. Chimeric Antigen Receptor T-Cell Therapy for B-Cell Cancers: Effectiveness and Value

in asymptomatic patients who have completed initial treatment, unless high-level evidence suggests that such imaging will change the outcome. • Avoid the use of white cell stimulating factors for primary prevention of febrile neutropenia in patients whose risk for this complication is less than 20%. Comparative Clinical Effectiveness The comparative clinical effectiveness review of the CAR-T therapies with other salvage therapies for ALL or DLBCL was challenging because all of the clinical studies were small (...) % Febrile Neutropenia 13% 13% Tumor Lysis Syndrome 1% 1% There were no deaths or reported cases of cerebral edema. Finally, there are theoretical concerns about mutagenesis from the insertion of the transgene into the patient’s T-cells for both CAR-T therapies. The risk is likely to be quite low, but is an important long-term concern for further study. Controversies and Uncertainties First, as highlighted throughout the review, the studies of CAR-T therapies are all single-arm trials. Given

2018 California Technology Assessment Forum

71. Diagnosis and management of polycythaemia vera Full Text available with Trip Pro

Recommended diagnostic criteria for PV JAK2‐positive polycythaemia vera (requires both criteria) A1 High haematocrit (>0·52 in men, >0·48 in women) OR raised red cell mass (>25% above predicted) A2 Mutation in JAK 2 JAK2‐negative polycythaemia vera (requires A1‐A4 plus another A or two B criteria) a This is a very rare clinical entity. A1 Raised red cell mass (>25% above predicted) OR haematocrit ≥0·60 in men, ≥0·56 in women A2 Absence of mutation in JAK 2 A3 No cause of secondary erythrocytosis A4 Bone (...) marrow histology consistent with polycythaemia vera A5 Palpable splenomegaly A6 Presence of an acquired genetic abnormality (excluding BCR‐ABL1 ) in the haematopoietic cells B1 Thrombocytosis (platelet count >450 × 10 9 /l) B2 Neutrophil leucocytosis (neutrophil count >10 × 10 9 /l in non‐smokers, ≥12·5 × 10 9 /l in smokers) B3 Radiological evidence of splenomegaly B4 Low serum erythropoietin a This is a very rare clinical entity. Table 2. Causes of erythrocytosis Primary Secondary Congenital

2018 British Committee for Standards in Haematology

72. Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia

time ASO PCR allele specific oligonucleotide polymerase chain reaction AST aspartate aminotransferase Bcl B cell lymphoma BCRi B Cell receptor inhibitor BMI body mass index BR bendamustine rituximab CD cluster of differentiation CI confidence interval CLL chronic lymphocytic leukaemia CPP Critical process parameter CQA Critical Quality Attribute CR complete remission CRi complete remission with incomplete bone marrow recovery CSR clinical study report CT computed tomography CTLS clinical tumour (...) 2.2.3. Finished Medicinal Product 14 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 17 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 18 2.2.6. Recommendations for future quality development 18 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 19 2.3.3. Pharmacokinetics 23 2.3.4. Toxicology 25 2.3.5. Ecotoxicity/environmental risk assessment 31 2.3.6. Discussion on non-clinical aspects 33 2.3.7. Conclusion on the non-clinical

2017 European Medicines Agency - EPARs

73. Trumenba - meningococcal group b vaccine (recombinant, adsorbed)

. the classical complement cascade is initiated, ultimately resulting in the formation of a membrane attack complex late in the cascade by complement components C5-C9; and 4. insertion of the membrane attack complex into the meningococcal membrane resulting in bacterial cell lysis 2.1.3. Clinical presentation MnB disease has a sudden onset and fast progression, even in healthy individuals. Patients may initially present with a nonspecific febrile illness characterized by headache and fatigue but then progress (...) . Epidemiology and risk factors, screening tools/prevention 8 2.1.3. Clinical presentation 11 2.1.4. Management 11 2.1.5. About the product 12 2.2. Quality aspects 13 2.2.1. Introduction 13 2.2.2. Active Substance 13 2.2.3. Finished Medicinal Product 16 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 18 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 20 2.2.6. Recommendation(s) for future quality development 20 2.3. Non-clinical aspects 20 2.3.1. Introduction 20

2017 European Medicines Agency - EPARs

74. Rituximab (Truxima) - follicular lymphoma and diffuse large B cell non-Hodgkin?s lymphoma, chronic lymphocytic leukaemia, severe rheumatoid arthritis, granulomatosis with polyangiitis

measurable concentration after the second infusion AUC0-t Area under the serum concentration-time curve from the start of first infusion to start of the second infusion AUCt-8 Area under the serum concentration-time curve from the start of second infusion to infinity BA Bioavailability BE Bioequivalence CCP Cyclic citrullinated protein CD CDAI Circular dichroism Clinical disease activity index CDC Complement-dependent cytotoxicity CHO CHOP Chinese Hamster Ovary Cyclophosphamide, doxorubicin, vincristine (...) Fc gamma receptor 3a (CD16a) V type receptor European league against rheumatism FcRn GCP neonatal Fc receptor Good clinical practice GI Gastrointestinal GMP GPA Good Manufacturing Practice Granulomatosis with polyangiitis HACA Human anti-chimeric antibodies HAQ Health assessment questionnaire disability index HBV Hepatitis B virus HCP HMW Host Cell Protein Higher Molecular Weight ICH Ig International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals

2017 European Medicines Agency - EPARs

75. Screening and Management of Late and Long-term Consequences of Myeloma and its Treatment

system is expected to be used increasingly in trials and may prove useful in the clinic. As this frailty index found age >75 years to be a risk factor for increased mortality and toxicity, a reasonable minimum is to assess all patients aged =75 years and any others with a sug- gestion of frailty. Recommendations Assessment. • Consider a baseline geriatric assessment in elderly and frail patients, particularly those aged =75 years (Grade 2C). • Consider using the outcome of an assessment to guide (...) University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK Summary A growing population of long-term survivors of myeloma is now accumulating the ‘late effects’ not only of myeloma itself, but also of several lines of treatment given throughout the course of the disease. It is thus important to recognise the cumulative burden of the disease and treatment-related toxicity in both the stable and active phases of myeloma, some of which is unlikely to be detected by routine monitor- ing. We

2017 British Committee for Standards in Haematology

76. Guideline for the management of adults with Systemic Lupus Erythematosus Full Text available with Trip Pro

in the UK in 2012 [ ] and was most frequently observed in people of African-Caribbean and South Asian descent [ ]. The age-standardized incidence in the UK according to the Clinical Practice Research Datalink is 8.3/100 000/year for females and 1.4/100 000/year for males [ ], and the highest incidence rates are seen in those of African-Caribbean descent: 31.4/100 000/year, compared with 6.7/100 000/year for those of white European descent. The mean age at diagnosis is 48.9 years [ ], but it is lower (...) to the EULAR/ERA-EDTA recommendations for LN [ ] and provide their strengths of agreement (SOAs) with a summary of the most important items in those recommendations ( ). T able 1 Levels of evidence and grades of recommendation for diagnosis, assessment and monitoring of non-renal SLE Statement/item Number of studies Overall SIGN level of evidence Grade of recommendation Selected references covering items discussed in text Diagnosis from clinical and serological features Prognostic value of: Clinical

2017 British Society for Rheumatology

77. Prevention, Diagnosis & Management of infective endocarditis

: • These conditions merit a high index of suspicion of IE (refer Sections 7.3 & 7.4). • In these patients, once a diagnosis of IE has been established or if there is strong clinical suspicion of IE, the patient should be sent to a specialist centre (refer Section 4.1.4). • The epidemiology of paediatric IE has evolved to reflect those with the advancement of interventions for CHD. It now broadly reflects the following groups: > Patients with prolonged use of central venous catheters in: » Corrected CHD during (...) examination. • Laboratory investigations. • Microbiological investigations. • Histopathological examinations; HPE (when possible). • Imaging, namely echocardiography and radiological investigations. In difficult cases, consultation with other experts such as ID specialists, cardiac imaging specialists and microbiologists may be required.30 3.1 Clinical evaluation of suspected infective endocarditis The most common symptom at presentation (up to 87%) is fever associated with chills, poor appetite

2017 Ministry of Health, Malaysia

78. Imaging Program Guidelines: Pediatric Imaging

Pseudotumor cerebri Seizures and epilepsy Neonatal/Infantile seizure (age 2 years or younger) ? Initial evaluation of seizure not associated with fever ? Periodic follow-up at 6-month intervals up to 30 months, if initial imaging study is non-diagnostic Childhood/Adolescent seizure (over age 2) ? When at least one of the following is present: ? Focal neurologic findings at the time of the seizure ? Persistent neurologic deficit in the postictal period ? Idiopathic epilepsy with atypical clinical course (...) (over age 2) ? When at least one of the following is present: ? Focal neurologic findings at the time of the seizure ? Persistent neurologic deficit in the postictal period ? Idiopathic epilepsy with atypical clinical course ? Partial seizures ? Seizures increasing in frequency and severity despite optimal medical management ? Electroencephalogram (EEG) findings inconsistent with idiopathic epilepsy Complex febrile seizure (age 6 months – 5 years) ? When either of the following is present: ? More

2017 AIM Specialty Health

79. Treatment Options for Relapsed or Refractory Multiple Myeloma

Treatment Options for Relapsed or Refractory Multiple Myeloma ©Institute for Clinical and Economic Review, 2016 Treatment Options for Relapsed or Refractory Multiple Myeloma: Effectiveness, Value, and Value-Based Price Benchmarks Final Evidence Report and Meeting Summary June 9, 2016 Institute for Clinical and Economic Review ©Institute for Clinical and Economic Review, 2016 Page ii Final Evidence Report – Multiple Myeloma Return to Table of Contents AUTHORS ICER Staff University of Washington (...) School of Pharmacy Modeling Group Daniel A. Ollendorf, PhD Chief Scientific Officer, Institute for Clinical and Economic Review Rick Chapman, PhD, MS Director of Health Economics, Institute for Clinical and Economic Review Sonya Khan, MPH Program Director, Institute for Clinical and Economic Review Elizabeth T. Russo, MD Research Scientist, Institute for Clinical and Economic Review Patricia G. Synnott, MALD, MS Research Associate, Institute for Clinical and Economic Review Steven D. Pearson, MD, MSc

2017 California Technology Assessment Forum

80. 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)

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