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Clinical Index of Stable Febrile Neutropenia

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121. Gazyvaro - obinutuzumab

for future quality development 27 2.3. Non-clinical aspects 27 2.3.1. Introduction 27 2.3.2. Pharmacology 27 2.3.3. Pharmacokinetics 31 2.3.4. Toxicology 33 2.3.5. Ecotoxicity/environmental risk assessment 36 2.3.6. Discussion on non-clinical aspects 37 2.3.7. Conclusion on the non-clinical aspects 39 2.4. Clinical aspects 40 2.4.1. Introduction 40 2.4.2. Pharmacokinetics 41 2.4.3. Pharmacodynamics 44 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 study(ies) 46 2.5.2. Main study(ies) 47 2.5.3. Discussion on clinical efficacy 86 2.5.4. Conclusions on the clinical efficacy 89 2.6. Clinical safety 89 2.6.1. Discussion on clinical safety 106 2.6.2. Conclusions on the clinical safety 113 2.7. Pharmacovigilance 113 2.8. Risk Management Plan 114 2.9. User consultation 118 3. Benefit-Risk Balance 119 4. Recommendations 121 CHMP assessment report EMA/CHMP/231450/2014 Page 3/123 List of abbreviations ADCC antibody

2014 European Medicines Agency - EPARs

122. Sylvant - siltuximab

) (Gaba 1978; van Rhee 2010). Unicentric Castleman’s disease is most commonly asymptomatic whereas MCD, first described by Gaba in 1978, displays a wide variety of clinical symptoms (Gaba 1978). MCD can occur in association with HIV and HHV-8 infection, but in the majority of patients, MCD occurs in the absence of these viral infections (Casper 2005; Dispenzieri 2012). Clinical symptoms of MCD may include fever, night sweats, fatigue, anorexia, weight loss, hepatosplenomegaly, palpable lymphadenopathy (...) 2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Active Substance 11 2.2.3. Finished Medicinal 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. Recommendations 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 22 2.3.4. Toxicology 23 2.3.5. Ecotoxicity/environmental risk assessment 27 2.3.6

2014 European Medicines Agency - EPARs

123. Zydelig - idelalisib

stability studies results indicate that the active substance manufactured by the proposed supplier is sufficiently stable. The stability results justify the proposed retest period in the proposed container. 2.2.3. Finished Medicinal Product Description of the product and pharmaceutical development The aim of the drug development was to develop an immediate release solid dosage formulation that could support patient adherence to the treatment. Idelalisib was first evaluated in Phase 1 clinical trials (...) . Finished Medicinal Product 13 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 15 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 16 2.3.3. Pharmacokinetics 21 2.3.4. Toxicology 21 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 35

2014 European Medicines Agency - EPARs

124. Olysio - simeprevir

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 2.3. Non-clinical aspects 15 2.3.1. Introduction 15 2.3.2. Pharmacology 16 2.3.3. Pharmacokinetics 18 2.3.4. Toxicology 22 2.3.5. Ecotoxicity/environmental risk assessment 25 2.3.6. Discussion on non-clinical aspects 27 2.3.7. Conclusion on the non-clinical aspects 28 2.4. Clinical aspects 29 2.4.1. Introduction 29 2.4.2. Pharmacokinetics 32 (...) 2.4.3. Pharmacodynamics 36 2.4.4. Discussion on clinical pharmacology 40 2.4.5. Conclusions on clinical pharmacology 42 2.5. Clinical efficacy 43 2.5.1. Dose response study(ies) 43 2.5.2. Main studies 44 2.5.3. Discussion on clinical efficacy 85 2.5.4. Conclusions on the clinical efficacy 89 2.6. Clinical safety 91 2.6.1. Discussion on clinical safety 107 2.6.2. Conclusions on the clinical safety 109 2.7. Pharmacovigilance 110 2.8. Risk Management Plan 110 2.9. User consultation 121 Assessment

2014 European Medicines Agency - EPARs

125. Rezolsta - darunavir / cobicistat

on the procedure 6 1.1. Submission of the dossier 6 1.2. Manufacturers 7 1.3. Steps taken for the assessment of the product 7 2. Scientific discussion 8 2.1. Introduction 8 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active Substance 9 2.2.3. Finished Medicinal Product 12 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 15 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.6. Recommendation(s) 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 22 2.3.6. Discussion on non-clinical aspects 23 2.3.7. Conclusion on the non-clinical aspects 23 2.4. Clinical aspects 24 2.4.1. Introduction 24 2.4.2. Pharmacokinetics 24 2.4.3. Pharmacodynamics 52 2.4.4. Discussion on clinical pharmacology 58 2.4.5. Conclusions on clinical pharmacology 59 2.5. Clinical efficacy 60 2.5.1. Main study 61 2.5.2

2014 European Medicines Agency - EPARs

126. Imbruvica - ibrutinib

(one capsule) when used concomitantly with moderate CYP3A4 inhibitors. It should be reduced to 140 mg once daily (one capsule) or withheld for up to 7 days when it is used concomitantly with strong CYP3A4 inhibitors. Recommended dose modifications for any new onset or worsening grade = 3 non-haematological toxicity, grade 3 or greater neutropenia with infection or fever, or grade 4 haematological toxicities are described below: Toxicity occurrence MCL dose modification after recovery CLL dose (...) , pharmaceutical and biological aspects 17 2.2.5. Recommendation(s) for future quality development 17 2.3. Non-clinical aspects 17 2.3.1. Introduction 17 2.3.2. Pharmacology 18 2.3.3. Pharmacokinetics 23 2.4. Absorption 23 2.5. Metabolism 24 2.6. Excretion 25 2.6.1. Toxicology 25 2.6.2. Ecotoxicity/environmental risk assessment 33 2.6.3. Discussion on non-clinical aspects 34 2.6.4. Conclusion on the non-clinical aspects 37 2.7. Clinical aspects 38 2.7.1. Introduction 38 2.7.2. Pharmacokinetics 39 2.7.3

2014 European Medicines Agency - EPARs

127. Daklinza - daclatasvir

oral dose, the highest dose was associated with a reversible moderate increased systolic, diastolic and mean arterial pressure in 4 out of 6 dogs. A 10 Daklinza EMA/CHMP/294323/2014 Page 14/145 to 15% decrease in a calculated index of cardiac contractility was also seen in 4 dogs. The no effect level for cardiovascular effects was 15 mg/kg, which corresponds to a Cmax of 2-4 µg/mL. This is approximately the same plasma level as the clinical levels reached at maximum recommended human dose (...) on chemical, pharmaceutical and biological aspects 12 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 13 2.3. Non-clinical aspects 13 2.3.1. Introduction 13 2.3.2. Pharmacology 13 2.3.3. Pharmacokinetics 14 2.3.4. Toxicology 16 2.3.5. Ecotoxicity/environmental risk assessment 24 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. Pharmacokinetics 40 2.4.2. Pharmacodynamics 41 2.4.3. Discussion on clinical

2014 European Medicines Agency - EPARs

128. Clopidogrel/Acetylsalicylic acid Teva

Teva International non-proprietary name: clopidogrel / acetylsalicylic acid Procedure No. EMEA/H/C/002272/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Medicinal product no longer authorised Assessment report EMA/502333/2014 Page 2/43 Table of contents 1. Background information on the procedure 6 2. Scientific discussion 8 2.1. Quality aspects 8 2.2. Non-clinical aspects 13 2.3. Clinical aspects 19 2.4. Clinical efficacy 28 (...) 2.5. Clinical safety 30 2.6. Pharmacovigilance 33 2.7. Risk Management Plan 34 2.8. Product information 39 3. Benefit-Risk Balance 39 Benefit-risk balance 41 4. Recommendations 42 Medicinal product no longer authorised Assessment report EMA/502333/2014 Page 3/43 List of abbreviations AA Arachidonic acid ACE Angiotensin converting enzyme ACS Acute coronary syndrome ADP Adenosine diphosphate AE Adverse event Al(u) Aluminium ANOVA Analysis of variance ASA Acetylsalicylic acid AUC Area under the curve

2014 European Medicines Agency - EPARs

129. Isavuconazonium sulfate (BAL8557) (Cresemba)

, but with an indolent, or slowly progressing infection. The partial and complete success rate of 36.4% (4/11 patients) in the refractory group provides support for efficacy, as this represents a salvage regimen. Additionally, 31.6% of primary therapy patients were assessed to be stable (no progression of infection), which is a clinically relevant favorable outcome in this typically immunosuppressed patient population. The study report did not discuss reductions in patient immunosuppression, as increasing host (...) Isavuconazonium sulfate (BAL8557) (Cresemba) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207500Orig1s000 / 207501Orig1s000 MEDICAL REVIEW(S) Clinical Review Edward Weinstein, MD, PhD NDA 207500 and 207501, 505 (b)(1) Cresemba ® (Isavuconazonium Sulfate) 1 CLINICAL REVIEW Application Type NDA 505 (b)(1) Application Number(s) 207500 and 207501 Priority or Standard Priority Submit Date(s) July 8, 2014 Received Date(s) July 8, 2014 PDUFA Goal Date March 8, 2015 Division / Office

2014 FDA - Drug Approval Package

130. Dinutuximab (Unituxin)

reduction and in patients who experience loss of vision [see Dosage and Administration (2.3)]. 5.7 Bone Marrow Suppression In Study 1, severe (Grade 3 or 4) thrombocytopenia (39% vs. 25%), anemia (34% vs. 16%), neutropenia (34% vs. 13%), and febrile neutropenia (4% vs. 0 patients) occurred more commonly in patients in the Unituxin/RA group compared to patients treated with RA alone. Monitor peripheral blood counts closely during therapy with Unituxin. Reference ID: 3711777Addendum to Clinical Review (...) morphine sulfate (50 mcg/kg) intravenously immediately prior to initiation of Unituxin and then continue as a morphine sulfate drip at an infusion rate of 20 to 50 mcg/kg/hour during and for two hours following completion of Unituxin. ? Administer additional 25 mcg/kg to 50 mcg/kg intravenous doses of morphine sulfate as needed for pain up to once every 2 hours followed by an increase in the morphine sulfate infusion rate in clinically stable patients. ? Consider using fentanyl or hydromorphone

2014 FDA - Drug Approval Package

131. Secukinumab (Cosentyx)

Secukinumab (Cosentyx) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125504Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type BLA Application Number(s) 125-504 Priority or Standard S Submit Date(s) October, 22, 2013 Received Date(s) October 24, 2013 PDUFA Goal Date January 23, 2015 Division / Office DDDP/ OND Reviewer Name(s) Amy Woitach Review Completion Date December 2, 2014 Established Name Secukinumab (Proposed) Trade Name Cosentyx Therapeutic Class Biologic (...) with Consideration to Related Drugs 13 2.5 Summary of Presubmission Regulatory Activity Related to Submission 14 2.6 Other Relevant Background Information 14 3 ETHICS AND GOOD CLINICAL PRACTICES 14 3.1 Submission Quality and Integrity 14 3.2 Compliance with Good Clinical Practices 15 3.3 Financial Disclosures 15 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES 15 4.1 Chemistry Manufacturing and Controls 15 4.2 Clinical Microbiology 16 4.3 Preclinical Pharmacology/Toxicology 16 4.4

2014 FDA - Drug Approval Package

132. Management of Cervical Cancer

is included and the content is not changed, not sold, nor used to promote or endorse any product or service, and not used in an inappropriate or misleading context. ISBN: 978-967-0769-27-1 Available on the following websites: http://www.moh.gov.my http://www.acadmed.org.my http://www.malaysiaoncology.org http://www.themgcs.blogspot.com Also available as an app for Android and iOS Platform: MyMaHTAS STATEMENT OF INTENT These clinical practice guidelines (CPG) are meant to be guides for clinical practice (...) , based on the best available evidence at the time of development. Adherence to these guidelines may not necessarily guarantee the best outcome in every case. Every healthcare provider is responsible for the management of his/her unique patient based on the clinical picture presented by the patient and the management options available locally. These guidelines were issued in 2015 and will be reviewed in 2019 or sooner if new evidence becomes available. When it is due for updating, the Chairman

2015 Ministry of Health, Malaysia

133. Muscle-invasive and Metastatic Bladder Cancer

into their clinical practice. Separate EAU guidelines documents are available addressing upper urinary tract tumours [1], non- muscle-invasive bladder cancer (Ta,T1 and carcinoma in situ) [2], and primary urethral carcinomas [3]. 1.2 Panel Composition The EAU Guidelines Panel consists of an international multidisciplinary group of experts from the fields of urology, pathology, radiology and oncology. All experts involved in the production of this document have submitted potential conflict of interest statements (...) . Recommendations have been rephrased and added to throughout the current document: 3.3.3 Recommendations for the assessment of tumour specimens Mandatory evaluations Depth of invasion (categories pT2 vs pT3a, pT3b or pT4); Margins with special attention paid to the radial margin, prostate, ureter, urethra and peritoneal fat and uterus and vaginal top. Histological subtype, if it has clinical implications; Extensive lymph node r epr esentation (mor e than nine); Optional evaluations Bladder wall blood vessel

2015 European Association of Urology

134. Prostate Cancer

Classification 17 5. DIAGNOSTIC EVALUATION 19 5.1 Screening and early detection 19 5.1.1 Guidelines for screening and early detection 20 5.2 Clinical diagnosis 20 5.2.1 Digital rectal examination 21 5.2.2 Prostate-specific antigen 21 5.2.2.1 PSA density 21 5.2.2.2 PSA velocity and doubling time 21 5.2.2.3 Free/total PSA ratio 21 5.2.2.4 Prostate Health Index (PHI) test 21 5.2.2.5 PCA3 marker 22 5.2.3 Prostate biopsy 22 5.2.3.1 Baseline biopsy 22 5.2.3.2 Repeat biopsy after previously negative biopsy 22 (...) with f/t PSA 0.25 [57]. f/t PSA is of no clinical use if total serum PSA is > 10 ng/mL or during follow-up of known PCa. f/t PSA must be used cautiously because it may be adversely affected by several preanalytical and clinical factors (e.g., instability of free PSA at 4°C and room temperature, variable assay characteristics, and concomitant BPH in large prostates) [58]. 5.2.2.4 Prostate Health Index (PHI) test The Prostate Health Index (PHI) test is a recently approved diagnostic blood test

2015 European Association of Urology

135. Secondary Prevention After Coronary Artery Bypass Graft Surgery Full Text available with Trip Pro

graft patency, , clopidogrel is 7-fold more potent and free of the unfavorable side effect profile of ticlopidine, which includes neutropenia and rash. Combining aspirin therapy with clopidogrel leads to potent synergistic antithrombotic effects, and substantial benefits have been demonstrated in several CAD trials studying the impact of dual antiplatelet therapy. , The potential clinical benefits of clopidogrel administration after CABG were first evaluated in subgroup analyses from the Clopidogrel (...) of adverse cardiovascular outcomes. Postoperative antiplatelet agents and lipid-lowering therapy continue to be the mainstay of secondary prevention after coronary surgical revascularization. Other opportunities for improving long-term clinical outcomes after CABG include the aggressive management of hypertension and diabetes mellitus, smoking cessation, weight loss, and cardiac rehabilitation (CR). Secondary preventive therapies help maintain long-term graft patency and help patients obtain the highest

2015 American Heart Association

136. Antibody-Mediated Rejection in Cardiac Transplantation: Emerging Knowledge in Diagnosis and Management Full Text available with Trip Pro

of the Council on Clinical Cardiology, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular Disease in the Young, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia Monica M. Colvin , Jennifer L. Cook , Patricia Chang , Gary Francis , Daphne T. Hsu , Michael S. Kiernan , Jon A. Kobashigawa , JoAnn Lindenfeld , Sofia Carolina Masri , Dylan Miller , John (...) O’Connell , E. Rene Rodriguez , Bruce Rosengard , Sally Self , Connie White-Williams , and Adriana Zeevi and on behalf of the American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular Disease in the Young, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery

2015 American Heart Association

137. Thiopurine S-methyltransferase testing for averting drug toxicity in patients receiving thiopurines: A systematic review and quality appraisal

Thiopurine S-methyltransferase testing for averting drug toxicity in patients receiving thiopurines: A systematic review and quality appraisal The Hospital for Sick Children Technology Assessment at SickKids (TASK) FULL REPORT THIOPURINE S-METHYLTRANSFERASE TESTING FOR AVERTING DRUG TOXICITY IN PATIENTS RECEIVING THIOPURINES: A SYSTEMATIC REVIEW AND QUALITY APPRAISAL Authors: Lilla M. Roy, RN, BScN, MSc Clinical Research Project Coordinator, Child Health Evaluative Services, The Hospital (...) . Ungar, MSc, PhD The Hospital for Sick Children Peter Gilgan Centre for Research and Learning 11th floor, 686 Bay Street Toronto, ON, Canada M5G 0A4 tel: (416) 813-7654, extension 303487, fax: (416) 813-5979, e-mail: wendy.ungar@sickkids.ca http://www.sickkids.ca/AboutSickKids/Directory/People/U/Wendy-Ungar.html Report No. 2015-02 Date: July 29, 2015 Available at: http://lab.research.sickkids.ca/task/reports-theses/ Co-investigators: Joseph Beyene, MSc, PhD Department of Clinical Epidemiology

2015 SickKids Reports

138. Acute Pain Management: Scientific Evidence

appropriate advice, before relying on the information in any important matter. Enquiries on the content of the material should be directed to the Therapeutic Goods Administration (www.tga.gov.au). Disclaimer This document aims to combine a review of the best available evidence for acute pain management with current clinical and expert practice, rather than to formulate specific clinical practice recommendations. It is designed to provide information based on the best evidence available at the time (...) of publication to assist in decision-making. The information provided is not intended to over-ride the clinical expertise of health care professionals and its use is subject to the clinician’s judgement and the patient’s preference in each individual case. There is no substitute for the skilled assessment of each individual patient’s health status, circumstances and perspectives, which health care practitioners will then use to select the treatments that are relevant and appropriate to that person

2015 Clinical Practice Guidelines Portal

139. Diagnosis and Management of Aplastic Anaemia

Protocols and guidelines for the management of febrile neutropenia, including the assessment and management of fungal infections, are well developed and clinicians should follow local hospital and National Institute for Health and Care Excellence guidance (Phillips et al , ). Empirical anti‐fungal therapy, as per local guidelines, should be initiated early for patients with clinically suspected IFIs, as these patients have persistent neutropenia. Granulocyte transfusions may be potentially life saving (...) according to co‐morbidities. Grade 1A Phenotype (Rh and Kell) matched blood should be considered to reduce the risk of alloimmunization. Grade 1B Prophylactic platelet transfusions should be given to stable AA patients receiving active treatment. Grade 1B. A threshold (pre‐transfusion) platelet count of 10 × 10 9 /l should be used. Grade 1B In patients judged to have additional risk factors for bleeding, such as fever or sepsis, a higher prophylactic transfusion threshold of 20 × 10 9 /l is recommended

2015 British Committee for Standards in Haematology

140. Teriflunomide - Multiple Sclerosis, relapsing

clinical sign/symptom or clinical worsening of a previous sign/symptom (stable for at least 30 days) that persisted for a minimum of 24 hours without fever. ? Multiple Sclerosis Functional Composite (MSFC) — used to assess ambulation, upper limb dexterity, and cognition using the following: the Timed 25-Foot Walk Test, Nine-Hole Peg Test, and three-second Paced Auditory Serial Addition Test. ? Health-related quality of life — assessed using the SF-36 Health Survey, the European Quality of Life-5 (...) that, without evidence demonstrating superior clinical benefit with teriflunomide compared with other available treatments for RRMS, a higher cost for teriflunomide is not justified. Of Note: Based on a review of the clinical evidence, CDEC noted that a reduction in price would increase the likelihood of a recommendation to list or list with clinical criteria and/or conditions. Background: Teriflunomide is an immunomodulatory drug with anti-inflammatory properties that selectively and reversibly inhibits

2014 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

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