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Clinical Index of Stable Febrile Neutropenia

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61. 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

62. Rituximab (Blitzima) - 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)

Circular dichroism Clinical disease activity index CDC Complement-dependent cytotoxicity CHO CHOP Chinese Hamster Ovary Cyclophosphamide, doxorubicin, vincristine, prednisolone CI Confidence interval CIPT CL Critical In-process Test Total body clearance CLL Chronic lymphocytic leukaemia CLT1 Cmax CELLTRION Plant I Maximum serum concentration after the second infusion CLT2 Cmax, 1 CELLTRION Plant II Maximum serum concentration after the first infusion Cmin Minimum serum concentration immediately before (...) Electrochemiluminescence Fc?RI ESR Fc gamma receptor R1 (CD64) Erythrocyte sedimentation rate Assessment report EMA/CHMP/421793/2017 Page 5/161 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

2017 European Medicines Agency - EPARs

63. 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

64. 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

65. 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

66. 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

67. Treatment for Bipolar Disorder in Adults: A Systematic Review

for the application 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

2018 Effective Health Care Program (AHRQ)

68. 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

69. 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

70. 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

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. Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update

. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application 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 (...) 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 periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site

2018 Effective Health Care Program (AHRQ)

73. 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

74. Obinutuzumab (Gazyvaro) - In combination with chemotherapy, followed by maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma (FL).

%, neutropenia 46% versus 40%, thrombocytopenia 6.1% versus 2.7%, infections, 20% versus 16%, and second malignancies 4.7% versus 2.7%. Deaths considered to be due to adverse events occurred in 4.0% (24/595) of patients treated with obinutuzumab versus 3.4% (20/597) of patients treated with rituximab. 2 Summary of clinical effectiveness issues Follicular lymphoma is a subtype of indolent NHL, which comprises about 70% of indolent NHL and about 20% to 25% of all new NHL. It is a mature B-cell neoplasm (...) to as higher) risk disease, follicular lymphoma international prognostic index (FLIPI) =2. The key evidence to support the indication under review is from GALLIUM, an ongoing, multicentre, phase III, open-label randomised study comparing obinutuzumab plus chemotherapy followed by obinutuzumab maintenance, with rituximab plus chemotherapy followed by rituximab maintenance, in 1,401 adults with previously untreated, histologically documented, advanced indolent non-Hodgkin’s lymphoma (NHL). A total of 1,202

2018 Scottish Medicines Consortium

75. 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

76. Antimicrobial Prophylaxis for Adult Patients with Cancer-Related Immunosuppression

physicians, nurses, and advanced practice providers who may treat patients with immunosuppression resulting from cancer treatment. Methods An Expert Panel convened to update clinical practice guideline recommendations on the basis of a systematic review of the medical literature. Key Recommendations A summary of antimicrobial prophylaxis recommendations can be found here and in . Antimicrobial prophylaxis: Recommendation 1.1: Risk of febrile neutropenia (FN) should be systematically assessed (...) and strength of recommendations, slide sets, and clinical tools and resources, at . Patient information is available at . Related ASCO Guidelines Recommendations for the Use of WBC Growth Factors Update. ( ) Central Venous Catheter Care for the Patient With Cancer. ( ) Hepatitis B Virus Screening for Patients With Cancer Before Therapy. Outpatient Management of Fever and Neutropenia in Adults Treated for Malignancy. © 2018 by American Society of Clinical Oncology R.A.T. and C.R.F. were Expert Panel Co

2018 American Society of Clinical Oncology Guidelines

77. Muscle-invasive and Metastatic Bladder Cancer

., Sesterhenn I.A., editors. 2004, IARCC Press: Lyon. 58. Kapur, P., et al. Primary adenocarcinoma of the urinary bladder: value of cell cycle biomarkers. Am J Clin Pathol, 2011. 135: 822. 59. Ploeg, M., et al. Clinical epidemiology of nonurothelial bladder cancer: analysis of the Netherlands Cancer Registry. J Urol, 2010. 183: 915. 60. Beltran, A.L., et al. Clinicopathological characteristics and outcome of nested carcinoma of the urinary bladder. Virchows Arch, 2014. 465: 199. 61. Mukesh, M., et al. Small (...) , 2003. 169: 955. 66. Fossa, S.D., et al. Clinical significance of the “palpable mass” in patients with muscle-infiltrating bladder cancer undergoing cystectomy after pre-operative radiotherapy. Br J Urol, 1991. 67: 54. 67. Wijkstrom, H., et al. Evaluation of clinical staging before cystectomy in transitional cell bladder carcinoma: a long-term follow-up of 276 consecutive patients. Br J Urol, 1998. 81: 686. 68. Ploeg, M., et al. Discrepancy between clinical staging through bimanual palpation

2018 European Association of Urology

78. Prostate Cancer

characteristics of prostate cancer. Prostate, 2010. 70: 10. 144. Auprich, M., et al. Contemporary role of prostate cancer antigen 3 in the management of prostate cancer. Eur Urol, 2011. 60: 1045. 145. Nicholson, A., et al. The clinical effectiveness and cost-effectiveness of the PROGENSA(R) prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation. Health Technol Assess, 2015. 19: 1. 146. Wei, J.T., et al. Can urinary PCA3 (...) Broeck T., et al. A systematic review of oncological effectiveness and harms of primary local interventions for high-risk localized and locally advanced prostate cancer. PROSPERO International prospective register of systematic reviews, 2017. CRD42017078862 8. Willemse, P.M., et al. Systematic review of deferred treatment with curative intent for localised prostate cancer to explore heterogeneity of definitions, thresholds and criteria and clinical effectiveness. PROSPERO International prospective

2018 European Association of Urology

79. Neutropenic sepsis: Scenario: Management

therapy are often based on studies which include non-neutropenic patients due to the lack of epidemiology data [ ]. This approach is supported by the ESMO clinical guidelines, which highlight the importance of prompt recognition of possible infection and sepsis in people with febrile neutropenia and initial management within one hour of the recognition of suspected sepsis [ ]. Expert opinion in a review article notes that people with neutropenic sepsis who appear clinically stable can deteriorate (...) of the Multinational Association of Supportive Care in Cancer (MASCC) prognostic index This clinical prediction rule has been prospectively validated and may be used by hospital clinicians to assess the risk of complications and mortality in people with febrile neutropenia, to help guide management options [ ]. CKS recognises that this tool is unlikely to be used in the primary care setting. Low-risk patients who are likely to improve clinically without the development of serious complications may be deemed

2017 NICE Clinical Knowledge Summaries

80. 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

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