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Clinical Index of Stable Febrile Neutropenia

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81. 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

82. 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

83. 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

84. Telavancin (Vibativ)

HABP/VABP. The trials were randomized, double-blind, active-controlled, multicenter, and multinational. Subjects with Gram-positive HABP/VABP were randomized 1:1 to receive either TLV 10 mg/kg IV q 24 h or VAN 1 g IV q 12 h for 7 to 21 days. Study 0015 enrolled 761 subjects and Study 0019 enrolled 771 subjects. The prespecified primary efficacy analysis was clinical response at the test- of-cure (TOC) assessment, which occurred 7-14 days after the last dose of study drug. The noninferiority margin (...) (TLV-VAN) was prospectively set at 20%. For the noninferiority analyses, the as-treated (AT) and clinically evaluable (CE) populations were considered coprimary. The results of the applicant's prespecified primary analysis are shown in Table 1. Note that to address the Agency's concern regarding uncertainty whether subjects had the disease of interest, only subjects who fulfilled American Thoracic Society/Infectious Disease Society of America (ATS/IDSA) guidelines for diagnosis of HABP/VABP were

2013 FDA - Drug Approval Package

85. Xtandi - enzalutamide

Bono, 2010). This intravenous chemotherapy is complicated by febrile neutropenia, neutropenic deaths, and serious gastrointestinal side effects including diarrhoea. Recently, abiraterone acetate, an oral inhibitor of androgen biosynthesis, has been approved for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel after demonstrating a 3.9-month survival advantage over placebo (de Bono, 2011). Treatment with abiraterone acetate requires the co (...) . Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 Pharmacodynamic drug interactions 22 2.3.3. Pharmacokinetics 22 2.3.4. Toxicology 23 Single dose toxicity 23 Repeat dose toxicity 24 Genotoxicity 26 Carcinogenicity 26 Reproduction Toxicity 26 Toxicokinetic data 27 Local Tolerance 27 Other toxicity studies 27 2.3.5. Ecotoxicity/environmental risk assessment 28 2.3.6. Discussion on non-clinical aspects 29 2.3.7. Conclusion on the non-clinical aspects 32 2.4. Clinical aspects 32

2013 European Medicines Agency - EPARs

86. Perjeta - pertuzumab

) although the proportion of patients with severe or life-threatening febrile neutropenia and diarrhoea was higher in the pertuzumab group compared to the placebo group. Adverse events resulting in death were observed in 2.5% of patients in the placebo arm and in 2.0% of patients in the pertuzumab arm. In terms of balance of benefits and risks, the totality of data indicated that pertuzumab was associated with clinically and statistically significant benefits in a patient population with limited (...) Target Range CR Complete response CRC Cardiac Review Committee CrCL Creatinine clearance CRO Clinical Research Organization CTD Common Technical Document CYP450 Cytochrome P450 DDI Drug-drug interactions DMA Danish Medicines Agency EBC Early breast cancer ECG Electrocardiogram ECOG Eastern Cooperative Oncology Group ECLA Electrochemiluminescence assay ELISA Enzyme-linked Immunosorbent Assay EMA European Medicines Agency FACT-TOI-PFB Functional Assessment of Cancer Therapy – Trial Outcome Index

2013 European Medicines Agency - EPARs

87. Lonquex - lipegfilgrastim

Electrochemiluminescence E. Coli Escherichia coli ELISA Enzyme-linked immunosorbent assay EMA European Medicines Agency EMEA European Medicines Agency EORTC European Organisation for Research and Treatment of Cancer EU European Union FDA Food and Drug Administration FN Febrile neutropenia GCP Good clinical practice GGT Gamma-glutamyltransferase G-CSF Granulocyte colony stimulating factor GLP Good laboratory practice GM-CSF Granulocyte-Macrophage colony-stimulating factor hG-CSF human Granulocyte colony-stimulating (...) Products CI Confidence interval CL/f Total body clearance C max Maximum drug concentration in plasma/serum COPD Chronic obstructive pulmonary disease CPA Cyclophosphamide CPMP Committee for Proprietary Medicinal Products CRF Case report form CSR Clinical study report CTX Chemortherapy CV coefficient of variation DDL Drug dispensation log DIC Disseminated Intravascular Coagulopathy DSMB Data safety monitoring board DSN Duration of severe neutropenia DVT Deep vein thrombosis ECG Electrocardiogram ECL

2013 European Medicines Agency - EPARs

88. Belinostat (Beleodaq)

Belinostat (Beleodaq) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 206256Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number 206256 Priority or Standard Priority Submit Date December 8, 2013 Received Date December 9, 2013 PDUFA Goal Date August 8, 2014 Division / Office DHP/OHOP Reviewer Name Hyon-Zu Lee, Pharm.D. Review Completion Date May 16, 2014 Established Name Belinostat Trade Name Beleodaq Therapeutic Class Histone deacetylase inhibitor (...) Drugs 17 2.5 Summary of Presubmission Regulatory Activity Related to Submission 18 2.6 Other Relevant Background Information 21 3 ETHICS AND GOOD CLINICAL PRACTICES 21 3.1 Submission Quality and Integrity 21 3.2 Compliance with Good Clinical Practices 21 3.3 Financial Disclosures 22 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES 23 4.1 Chemistry Manufacturing and Controls 23 4.2 Clinical Microbiology 23 4.3 Preclinical Pharmacology/Toxicology 23 4.4 Clinical Pharmacology 24

2013 FDA - Drug Approval Package

89. Bosulif (bosutinib (as monohydrate))

and biological aspects 15 2.3. Non-clinical aspects 16 2.3.1. Introduction 16 2.3.2. Pharmacology 16 2.3.3. Pharmacokinetics 17 2.3.4. Toxicology 18 2.3.5. Ecotoxicity/environmental risk assessment 28 2.3.6. Discussion on non-clinical aspects 29 2.3.7. Conclusion on the non-clinical aspects 30 2.4. Clinical aspects 30 2.4.1. Introduction 30 2.4.2. Pharmacokinetics 35 2.4.3. Pharmacodynamics 40 2.4.4. Discussion on clinical pharmacology 41 2.4.5. Conclusions on clinical pharmacology 43 2.5. Clinical efficacy (...) 43 2.5.1. Dose response studies 44 2.5.2. Main studies 45 Supportive studies 56 2.5.3. Discussion on clinical efficacy 60 2.5.4. Conclusions on the clinical efficacy 64 2.6. Clinical safety 65 2.6.1. Discussion on clinical safety 75 2.6.2. Conclusions on the clinical safety 78 2.7. Pharmacovigilance 78 2.8. User consultation 81 3. Benefit-Risk Balance 81 4. Recommendations 85 Bosulif CHMP assessment report Page 3/87 List of abbreviations AE adverse event ALT aspartate aminotransferase AP

2013 European Medicines Agency - EPARs

90. Istodax - romidepsin

Licensing status 7 1.2. Steps taken for the assessment of the product 8 1.3. Steps taken for the re-examination procedure 9 2. Scientific discussion 10 2.1. Introduction 10 2.2. Quality aspects 12 Manufacture 13 Specification 13 Stability 14 Pharmaceutical Development 14 Adventitious agents 15 Manufacture of the product 15 Product specification 16 Stability of the product 16 2.3. Non-clinical aspects 19 Primary pharmacodynamic studies 19 Secondary pharmacodynamic studies 24 Safety pharmacology programme (...) 24 Pharmacodynamic drug interactions 26 Single dose toxicity 28 Repeat dose toxicity 29 Genotoxicity 34 Carcinogenicity 34 Reproduction Toxicity 34 Toxicokinetic data 35 Local Tolerance 35 Other toxicity studies 35 2.4. Clinical aspects 43 GCP 43 Absorption 45 Distribution 45 Elimination 46 Dose proportionality and time dependencies 46 Special populations 46 Pharmacokinetic interaction studies 46 Pharmacokinetics using human biomaterials 47 Mechanism of action 47 Primary and Secondary

2013 European Medicines Agency - EPARs

91. Teriflunomide

In general, these changes tend to occur early (within the first 6-12 weeks) and then remain stable. Reference ID: 3185084 19 Outliers The following chart displays the percent of patients who met criteria for potentially clinically important changes for the various laboratory analytes: Analyte Placebo Ter 7 Ter 14 Phosphorus >0.6 and 0.3 and 7 mmol/L 0.2% 1% 1% Creatinine >150 umol/L 0% 1% 1% > 2 X baseline 0% 1% 1% > 3 x Baseline 0% 1% 1% Uric acid 3 - 2.5 - 0.5 5% 10% 4.5% Lymphocytes 0.5 Giga/L 5% 7 (...) 6045) or glatiramer acetate (Study 6046) as additional support. The NDA has been reviewed by Drs. Prafull Shiromani and Sarah Miksinski, Office of New Drug Quality and Assessment (ONDQA, CMC); Dr. Tien-Mien Chen, ONDQA, Biopharmaceutics; Dr. Richard Houghtling, pharmacology/toxicology reviewer; Dr. Lois Freed, pharmacology supervisor; Dr. Matthew Jackson, statistician (carcinogenicity); Drs. Vaneeta Tandon, Joo-Yeon Lee, and Jeffrey Kraft, Office of Clinical Pharmacology; Dr. Katherine Bonson

2012 FDA - Drug Approval Package

92. Perampanel (Fycompa)

-emergent SAEs coded to the following preferred terms: aplastic anemia, agranulocytosis, Stevens Johnson syndrome, toxic 2 In the Parkinson’s disease studies, for example, subjects could have clinically significant, but stable disease; in the epilepsy studies, subjects with clinically significant disease were excluded. Reference ID: 3197631Safety Team Leader Memo NDA 202834 7 epidermal necrolysis, acute renal failure, acute liver failure, rhabdomyolysis, angioedema, or anaphylaxis. There was one SAE (...) Perampanel (Fycompa) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202834Orig1s000 MEDICAL REVIEW(S) Safety Team Leader Memo NDA 202834 1 Review and Evaluation of Clinical Data Safety Team Leader Memorandum ________________________________________________________________ NDA: 202834 Drug: Perampanel (FYCOMPA) Route: Oral Indication: Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization Sponsor: Eisai, Inc. Submission Date: 12/22/11

2012 FDA - Drug Approval Package

93. Adcetris (brentuximab vedotin)

, pharmaceutical and biological aspects 22 2.2.6. Recommendations for future quality development 22 2.3. Non-clinical aspects 23 2.3.1. Introduction 23 2.3.2. Pharmacology 23 2.3.3. Pharmacokinetics 25 2.3.4. Toxicology 28 2.3.5. Ecotoxicity/environmental risk assessment 33 2.3.6. Discussion on non-clinical aspects 34 2.3.7. Conclusion on the non-clinical aspects 40 2.4. Clinical aspects 40 2.4.1. Introduction 40 2.4.2. Pharmacokinetics 41 2.4.3. Pharmacodynamics 45 2.4.4. Discussion on clinical pharmacology (...) 45 2.4.5. Conclusions on clinical pharmacology 46 2.5. Clinical efficacy 46 2.5.1. Dose response studies 46 2.5.2. Main studies 47 Supportive studies 65 2.5.3. Discussion on clinical efficacy 68 2.5.4. Conclusions on the clinical efficacy 71 2.6. Clinical safety 72 2.6.1. Discussion on clinical safety 80 2.6.2. Conclusions on the clinical safety 84 2.7. Pharmacovigilance 84 2.8. User consultation 91 3. Benefit-Risk Balance 92 4. Recommendations 99 Adcetris CHMP assessment report Rev10.11 Page 3

2012 European Medicines Agency - EPARs

94. Alogliptin and alogliptin/pioglitazone

alone or in combination with metformin. Both the pioglitazone and metformin were stable for at least 8 weeks prior to Screening. Reference ID: 3247308 (b) (4)Clinical Review Valerie S.W. Pratt, M.D. NDAs 22-271 and 22-426 Nesina (alogliptin) and (alogliptin/pioglitazone FDC) 30 There was a 16 week treatment period and a follow-up visit 2 weeks after the end of treatment. The duration of the study for these subjects was approximately 24 weeks. Main Inclusion Criteria: • The subject has a historical (...) Alogliptin and alogliptin/pioglitazone CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022426Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Complete Response Application Number(s) 22-271 and 22-426 Priority or Standard Standard Submit Date(s) 7-26-12 Received Date(s) 7-26-12 PDUFA Goal Date 1-26-13 Division / Office DMEP/ODEII/OND Reviewer Name(s) Valerie S.W. Pratt, M.D. Review Completion Date 01-17-13 Established Name Alogliptin and alogliptin/pioglitazone FDC

2012 FDA - Drug Approval Package

95. Folotyn - pralatrexate

lymphoma DNA deoxyribonucleic acid dTMP deoxythymidine monophosphate EMA European Medicines Agency EU European Union FDA Food and Drug Administration FPGS folylpolyglutamyl synthetase G-CSF granulocyte colony stimulating factor GCP Good Clinical Practice GM-CSF granulocyte/macrophage colony stimulating factor HR hazard ratio HTLV human T-cell leukaemia virus ICH International Conference on Harmonisation IPI International Prognostic Index IWC International Workshop Criteria IV intravenous LFT liver (...) Prognostic Index, 5-year survival has been reported to be as low as 6%. Several clinical studies have reported a median survival of less than 2 years for patients with T-cell neoplasms and 5-year survival rates of less than 30%. Because of having an aggressive clinical course with poor outcomes, PTCL is typically treated with combination chemotherapy regimens like CHOP and its variants. The first-line response rates to CHOP chemotherapy have been reported to range between 50% and 70%. However, patients

2012 European Medicines Agency - EPARs

96. Zinforo - ceftaroline fosamil

on the chemical, pharmaceutical and biological aspects 18 2.2.6. Recommendation for future quality development 18 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 2.3.3. Pharmacokinetics 21 2.3.4. Ecotoxicity/environmental risk assessment 25 2.3.5. Discussion on non-clinical aspects 26 2.3.6. Conclusion on the non-clinical aspects 27 2.4. Clinical aspects 27 2.4.1. Introduction 27 2.4.2. Pharmacokinetics 34 2.4.3. Pharmacodynamics 41 2.4.4. Discussion on clinical pharmacology 43 (...) 2.4.5. Conclusions on clinical pharmacology 44 2.5. Clinical efficacy 44 2.5.1. Dose response studies 44 2.5.2. Main studies 46 2.5.3. Discussion on clinical efficacy 92 2.5.4. Conclusions on the clinical efficacy 94 2.6. Clinical safety 95 2.6.1. Discussion on clinical safety 105 2.6.2. Conclusions on the clinical safety 105 2.7. Pharmacovigilance 105 2.8. User consultation 119 3. 119 Benefit-Risk Balance 4. 121 RecommendationsZinforo Assessment report Page 4/122 List of abbreviations %T>MIC

2012 European Medicines Agency - EPARs

97. Pixuvri - pixantrone dimaleate

, pixantrone inhibited CYP1A2 at clinically relevant concentrations. The interaction has not been confirmed in vivo, however warnings in the SmPC for CYP1A2 substrates with narrow therapeutic index such as theophylline have been included (see SmPC section 4.5). The potential for pixantrone to reversibly inhibit CYP2B6 and CYP2C8 at clinically relevant concentration is low. Definite conclusions on the risk for inhibition of CYP2C8 activity cannot be drawn from the data submitted. Although the in vitro (...) and determined the dose limiting toxicity (DLT). There is a direct relationship between exposure and neutropenia. During the pivotal study after an initial decline from baseline to cycle 2, mean neutrophil nadirs remain stable through subsequent cycles. Data pooled from four single agent studies (AZA-I-01, 02, 03 and PIX 301) using different doses of pixantrone and in different cancer populations have shown a relationship between plasma exposure (AUC) and pharmacodynamic effect (PFS and neutropaenia

2012 European Medicines Agency - EPARs

98. Trifluridin/tipirACil in meTastatIc Colorectal Cancer

treatment to baseline CTCAE grades of the mentioned parameters will also be presented per visit using frequencies and percentages. Therapy management (use of relevant supportive medications) [ Time Frame: Baseline up to 3 years ] Number of patients receiving G-CSFs for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (Frequencies) Patient-reported outcomes (PROs) on quality of life (QoL) [ Time Frame: Baseline up to 3 years ] PRO-CTCAE: Questionnaire PRO-CTCAE is used to determine (...) Cancer (TACTIC) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03665506 Recruitment Status : Recruiting First Posted : September 11, 2018 Last Update Posted : September 11, 2018 See Sponsor: Servier Collaborator: iOMEDICO

2018 Clinical Trials

99. Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type

Frame: 12 months ] The duration of response (DoR) will be measured from the time of first documented response (CR or PR as per RECIST 1.1) until the first documented disease progression or death due to underlying cancer, or censored at the date of the last available tumor assessment. The clinical benefit rate (CBR) [ Time Frame: 8 weeks ] after 8 weeks of treatment will be defined as the proportion of patients with CR or PR or Stable disease (SD). It will be described on the efficacy-evaluable (...) population, together with its 95% CI. Tumor response will be evaluated according to RECIST 1.1. The clinical benefit rate (CBR) [ Time Frame: 16 weeks ] after 16 weeks of treatment will be defined as the proportion of patients with CR or PR or Stable disease (SD). It will be described on the efficacy-evaluable population, together with its 95% CI. Tumor response will be evaluated according to RECIST 1.1. Progression-Free Survival (PFS) [ Time Frame: 12 months ] will be measured from C1D1 until the date

2018 Clinical Trials

100. Chemo- and Targeted Therapy for Women with HER2 Negative (or unknown) Advanced Breast Cancer

(in particular febrile neutropenia). Bevacizumab should be investigated further in the second-line setting. O'Shaughnessy et al, 2012 Systematic review Seven prospective studies including 1,813 patients and four retrospective studies including 1,087 patients First-line capecitabine monotherapy demonstrated superior median survival compared with CMF combination therapy; all other comparisons for efficacy were nonsignificant. Capecitabine monotherapy (1,000 mg/m 2 twice daily, for 14 d of a 21-d cycle) has (...) Chemo- and Targeted Therapy for Women with HER2 Negative (or unknown) Advanced Breast Cancer Chemotherapy and Targeted Therapy for Women With Human Epidermal Growth Factor Receptor 2–Negative (or unknown) Advanced Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline | Journal of Clinical Oncology Search in: Menu Article Tools ASCO SPECIAL ARTICLES Article Tools OPTIONS & TOOLS COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2014.56.7479

2014 American Society of Clinical Oncology Guidelines

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