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Clinical Index of Stable Febrile Neutropenia

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41. 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 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 (...) Oncology - published online before print February 14, 2018 PMID: Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline x Julie R. Brahmer , x Christina Lacchetti , x Bryan J. Schneider , x Michael B. Atkins , x Kelly J. Brassil , x Jeffrey M. Caterino , x Ian Chau , x Marc S. Ernstoff , x Jennifer M. Gardner , x Pamela Ginex , x Sigrun Hallmeyer , x Jennifer Holter Chakrabarty , x

2018 American Society of Clinical Oncology Guidelines

42. 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 (...) of tisagenlecleucel in the JULIET trial are summarized in Table ES10 below. 29 Table ES10. Key Adverse Events in the JULIET Trial (n=99) Adverse Event All Grades Grade 3 or Higher Cytokine Release Syndrome 58% 23% Neurologic Toxicities 21% 12% Infections 34% 20% Cytopenias Not Resolved by Day 28 36% 27% 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

2018 California Technology Assessment Forum

43. 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

44. 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)

45. 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

46. 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

47. 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

48. 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

49. 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

50. Guidelines for the Management of Genital Herpes in New Zealand

Tests 9 Key Information to Discuss with a Patient Who Asks for a Blood Test 9 Table 1: Interpreting Blood Test Results 10 MANAGEMENT OF CLINICAL EPISODES OF GENITAL HERPES 10 Management of First Clinical Episode 12 Treatment algorithm – Management of First Episode of Genital Herpes 13 Treatment of First Episode Genital Herpes 14 Management of Recurrent Episodes of Genital Herpes 15 Treatment of Recurrent Genital Herpes 16 Genital Herpes in Immunocompromised Individuals 17 Treatment algorithm (...) – Management of Recurrent Episodes of Genital Herpes 18 GENITAL HERPES IN PREGNANCY 18 Maternal Fetal Transmission 19 Use of Antivirals in Pregnancy and Breastfeeding 19 Mode of Delivery 21 Special Situations in Pregnancy 21 Prevention of HSV in the Neonate 21 Summary of Clinical Management of First Episode Genital Herpes in Pregnancy 22 Treatment algorithm – Management of Women with Suspected Genital Herpes in Pregnancy 23 First Episode Genital Herpes: First and Second Trimester Acquisition 23 First

2017 New Zealand Sexual Health Society

51. Imaging Program Guidelines: Pediatric Imaging

(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 (...) Imaging Program Guidelines: Pediatric Imaging Clinical Appropriateness Guidelines: Advanced Imaging Imaging Program Guidelines: Pediatric Imaging Effective Date: November 20, 2017 Proprietary Guideline Last Revised Last Reviewed Administrative 07-26-2016 07-26-2016 Head and Neck 11-01-2016 11-01-2016 Chest 08-27-2015 07-26-2016 Abdomen and Pelvis 11-01-2016 11-01-2016 Spine 08-27-2015 07-26-2016 Extremity 08-27-2015 07-26-2016 Copyright © 2017. AIM Specialty Health. All Rights Reserved 8600 W

2017 AIM Specialty Health

52. 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 (...) Prevention, Diagnosis & Management of infective endocarditis CLINICAL PRACTICE GUIDELINES FOR THE PREVENTION, DIAGNOSIS & MANAGEMENT OF INFECTIVE ENDOCARDITISPUBLISHED BY: Clinical Practice Guidelines (CPG) Secretariat c/o Health Technology Assessment (HTA) Unit Medical Development Division Ministry of Health Malaysia 4 th floor, Block E1, Parcel E 62590 Putrajaya COPYRIGHT The owners of this publication are the National Heart Association of Malaysia (NHAM) and the Academy of Medicine Malaysia

2017 Ministry of Health, Malaysia

53. 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

54. 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 (...) Lymphoma CLINICAL PRACTICE GUIDELINE LYHE-002 Version 11 LYMPHOMA Effective Date: July 2018 The recommendations contained in this guideline are a consensus of the Alberta Provincial Hematology Tumour Team synthesis of currently accepted approaches to management, derived from a review of relevant scientific literature. Clinicians applying these guidelines should, in consultation with the patient, use independent medical judgment in the context of individual clinical circumstances to direct care

2016 CPG Infobase

55. 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

56. 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

57. 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

58. 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

59. 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

60. 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

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