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Clinical Index of Stable Febrile Neutropenia

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81. 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

82. 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

83. 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

84. 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

85. 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

86. Central Venous Catheter Care for the Patient With Cancer

Update of the Clinical Practice Guideline for the use of Antimicrobial Agents in Neutropenic Patients with Cancer. Information on the management of febrile neutropenia in the outpatient setting can be found at . Specific therapy with standard antimicrobial agents should be initiated as soon as possible. Catheter-related BSIs are most commonly caused by coagulase-negative staphylococci, Staphylococcus aureus , and Candida species and less commonly with Bacillus species, Corynebacterium jeikeium (...) source of infection. Many approaches to quantify the number of organisms cultured from each site have been proposed. Although not specific to patients with cancer, there are recommendations for culturing and treatment in the IDSA 2009 Update of the Clinical Practice Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infection (pocket card can be found at ). The use of antimicrobial agents in patients with cancer and/or neutropenia are also clearly addressed in the IDSA 2010

2013 American Society of Clinical Oncology Guidelines

87. Investigation and management of Chronic Lymphocytic Leukaemia

the course of the disease (Shanafelt et al , , ; Evans et al , ). The issue of patient communication from both the haematologist's and patient's perspective is discussed on the UK CLL Forum website ( ). Patients with early CLL should be reviewed at least twice within the first year from diagnosis to assess the rate of disease progression. For those with stable disease, particularly if they have ‘good risk’ clinical and/or laboratory features, monitoring can be extended to an annual check. This may (...) + cyclophosphamide; FCR, fludarabine + cyclophosphamide + rituximab; O, ofatumumab; BR, bendamustine + rituximab; NA, not available. Recommendation FCR is recommended as initial therapy for previously untreated fit patients outside clinical trials (Grade A1). Patients who progress after one cycle of FCR or who have stable disease after two cycles have high‐risk disease and should be managed accordingly (section 4.5.5 ). Initial treatment of unfit patients with no TP53 abnormality Chlorambucil remains widely used

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2012 British Committee for Standards in Haematology

88. Guidelines for the diagnosis and antibiotic treatment of endocarditis in adults: a report of the working party of BSAC

continue to be a problem. 2 For this reason we have attempted to highlight key clinical scenarios where IE should be considered. Initial investigation in this context may involve appropriate blood culture or echocardiography or both, depending on the index of suspicion or the situation. The clinical presentation is highly variable, according to the causative microorganism, the presence or absence of pre-existing cardiac disease, and the presence of co-morbidities and risk factors for the development (...) cases.Clinicaljudgementremainsessential,especiallyinsettings where the sensitivity of the modi?ed Duke criteria is diminished, e.g. when blood cultures are negative, when too few blood A febrile illness and a murmur of new valvular regurgitation; A febrile illness, a pre-existing at-risk cardiac lesion (see Figure 2) and no clinically obvious site of infection; A febrile illness associated with any of: Predisposition and recent intervention with associated bacteraemia, Evidence of congestive heart failure, New conduction disturbance

2012 British Infection Association

89. LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies

dose not to exceed 1200 mg/week. topotecan: orally, for first 5 days of each 21-day cycle. Maximum dose not to exceed 2.3 mg/m2 per day. Pegylated GCSF (PEG-GCSF) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan. Because patients treated with topotecan are at high risk of developing febrile neutropenia, GCSF will be given in the prophylactic setting. Dose Expansion: 24 additional patients will be treated at the MTD in 2 (...) . pegfilgrastim) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan. Because patients treated with topotecan are at high risk of developing febrile neutropenia, GCSF will be given in the prophylactic setting. Other Name: pegfilgrastim Outcome Measures Go to Primary Outcome Measures : The incidence of dose-limiting toxicities (DLTs) as a measure of safety and tolerability [ Time Frame: 21 days (one cycle) ] The maximum tolerated dose

2016 Clinical Trials

90. Axitinib in R/M Salivary Gland Cancers of the Upper Aerodigestive Tract

or within 4 weeks of study entry. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed) Major surgery within 2 weeks of start of study Use of biologic response modifiers, such as G-CSF, within 3 week of study entry [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted (...) with Inlyta®. These results prompted a phase II study to test the activity of axitinib in relapsed and/or metastatic and progressive ACC patients. Results were 9% of partial responses and 75% of stable disease as best overall response. Inlyta®, a potent VEGFR specific-inhibitor, has been approved by FDA as second line treatment for renal cancer. Based on preclinical and clinical data, we believe that targeting VEGFR might represent a rational basis to further test Inlyta® in patients with relapsed

2016 Clinical Trials

91. Lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinomas of the Salivary Glands: ACC-LEN14

entry. Previous therapy with lenvatinib (E7080) Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed) Major surgery within 2 weeks of start of study Use of biologic response modifiers, such as G-CSF, within 3 week of study entry [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may (...) in these parameters exists) Previous systemic therapy for metastatic disease is allowed for a maximum of 1 previous line of chemotherapy and/or 1 previous line of TKI Signed written informed consent Exclusion Criteria: Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry Subjects having > 1+ proteinuria on urine dipstick

2016 Clinical Trials

92. A Study Of The Safety And Effects Of One Or More Doses Of HSP-130 Injected Under The Skin In Women With Breast Cancer That Has Not Spread To Distant Sites In The Body.

the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 1 and Cycle 4 [ Time Frame: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose ] Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood. Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4 [ Time Frame: Cycle (...) 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose ] Febrile Neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 °C for >1 hour and ANC less than (<) 1.0 *10^9/L. Incidence of Severe Neutropenia: Cycle 1 and Cycle 4 [ Time Frame: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose ] Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L. Time to ANC Recovery: Cycle 1 and Cycle 4

2016 Clinical Trials

93. Irinotecan or oxaliplatin combined with 5-fluorouracil and leucovorin as first-line therapy for advanced colorectal cancer: a meta-analysis

and leucovorin versus oxaliplatin combined with fluorouracil and leucovorin as first-line treatment for advanced or metastatic colorectal cancer were eligible for inclusion. Trials not analysed on intervention-to-treat basis were excluded. Outcome measures were clinical efficacy (complete and partial response, stable and progressive disease, response rate, time to progression, duration of response, overall survival) and adverse effects (grade 3 or 4 toxicities according to the National Cancer Institute (...) ; seven RCTs); diarrhoea (RR 1.71, 95% CI 1.34 to 2.18; seven RCTs); and alopecia (RR 14.56, 95% CI 4.11 to 51.66; n=791 patients; two RCTs). No differences between groups were found in the incidence of mucositis and febrile neutropenia. However, the incidence of neurotoxicity (RR 0.06, 95% CI 0.03 to 0.14; n=2,095; seven RCTs), neutropenia (RR 0.70, 95% CI 0.55 to 0.91; seven RCTs) and thrombocytopenia (RR 0.18, 95% CI 0.05 to 0.61; n=1,151; four RCTs) were lower in the irinotecan group compared

2010 DARE.

94. Addyi - Flibanserin

clinical practice are unknown. Estimates of the prevalence of HSDD in U.S. women vary widely, depending on the instruments used for assessment as well as menopausal status of the women studied. Two large survey studies have estimated the prevalence of HSDD in U.S. premenopausal women to be 7.7% to 14%, 2,3 potentially affecting 5.5 to 8.6 million U.S. women ages 20 to 49. However, methodological limitations inherent in these surveys, such as recall bias and low response rates (4.8% and 8.2 (...) %, respectively in West and Lieblum, et al.), makes it difficult to estimate the prevalence of HSDD in the U.S. There are no FDA approved pharmacotherapies to treat HSDD in either women or men. While psychological interventions – such as cognitive behavior therapy, sex therapy, or couples therapies – have been shown to decrease symptom severity in women with HSDD, 4 evidence from large, place-controlled clinical trials demonstrating effectiveness of psychological therapies is lacking. Testosterone has been

2015 FDA - Drug Approval Package

95. Kyprolis - carfilzomib

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 23 2.3.4. Toxicology 24 2.3.5. Ecotoxicity/environmental risk assessment 31 2.3.6. Discussion on non-clinical aspects 32 2.3.7. Conclusion on the non-clinical aspects 35 2.4. Clinical aspects 35 2.4.1. Introduction 35 2.4.2. Pharmacokinetics 35 2.4.3. Pharmacodynamics 41 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 studies 46 2.5.2. Main study 47 2.5.3. Discussion on clinical efficacy 86 2.5.4. Conclusions on the clinical efficacy 88 2.6. Clinical safety 88 2.6.1. Discussion on clinical safety 121 2.6.2. Conclusions on the clinical safety 127 2.7. Risk Management Plan 127 2.8. Pharmacovigilance 134 2.9. Product information 135 2.9.1. User consultation 135 2.9.2. Additional monitoring 135 Assessment report EMA

2015 European Medicines Agency - EPARs

96. Farydak - panobinostat

and biological aspects 17 2.2.6. Recommendations for future quality development 17 2.3. Non-clinical aspects 17 2.3.1. Introduction 17 2.3.2. Pharmacology 17 2.3.4. Toxicology 28 2.3.5. Ecotoxicity/environmental risk assessment 39 2.3.6. Discussion on non-clinical aspects 40 2.3.7. Conclusion on the non-clinical aspects 42 2.4. Clinical aspects 42 2.4.1. Introduction 42 2.4.2. Pharmacokinetics 43 2.4.3. Pharmacodynamics 49 2.4.4. Discussion on clinical pharmacology 50 2.4.5. Conclusions on clinical (...) pharmacology 53 2.5. Clinical efficacy 54 2.5.1. Dose response study 54 2.5.2. Main study 56 2.5.3. Discussion on clinical efficacy 84 2.5.4. Conclusions on the clinical efficacy 88 2.6. Clinical safety 89 2.6.1. Discussion on clinical safety 102 2.6.2. Conclusions on the clinical safety 107 2.7. Pharmacovigilance 107 2.8. Risk Management Plan 107 2.9. Product information 118 2.9.1. User consultation 118 Assessment report EMA/CHMP/496296/2015 Page 2/124 3. Benefit-Risk Balance 118 4. Recommendations 121

2015 European Medicines Agency - EPARs

97. 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

98. 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

99. 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

100. Sylvant - siltuximab

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 (...) . Discussion on non-clinical aspects 27 2.3.7. Conclusion on the non-clinical aspects 29 2.4. Clinical aspects 29 2.4.1. Introduction 29 2.4.2. Pharmacokinetics 30 2.4.3. Pharmacodynamics 33 2.4.4. Discussion on clinical pharmacology 35 2.4.5. Conclusions on clinical pharmacology 36 2.5. Clinical efficacy 36 2.5.1. Dose response study 37 2.5.2. Main study 39 2.5.3. Discussion on clinical efficacy 58 2.5.4. Conclusions on the clinical efficacy 61 2.6. Clinical safety 61 2.6.1. Conclusions on the clinical

2014 European Medicines Agency - EPARs

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