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Pipeline Insight: Leukemias Underserved patient populations offer potential for market growth
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Introduction
Despite major advances in treatment in the last decade, a considerable percentage of the leukemia population still has high unmet needs. Some key oncology companies have entered the leuk.....
Introduction Despite major advances in treatment in the last decade, a considerable percentage of the leukemia population still has high unmet needs. Some key oncology companies have entered the leukemias market fairly recently while others are pursuing late-phase development in this indication, hoping to exploit the commercial potential of patient subgroups underserved by existing treatment options. Scope *Forecast sales of the drugs in late-phase development for leukemia in the seven major markets over the period 2010 to 2019 *In-depth analysis for all leukemia drugs in late-phase development, including trial data, SWOT analysis and clinical and commercial potential *Segmentation and analysis of the leukemia pipeline by developmental phase, class and indication *Insight and analysis of leukemia market potential including epidemiology, patient segmentation, unmet needs and target product profiles Highlights Despite high cure rates in some forms of leukemia, certain groups of patients still have high unmet needs. Drug developers are targeting increasingly defined subsets of patients with high unmet need in order to establish a market for their products. Examples include elderly patients and patients with certain genetic characteristics. Chronic lymphocytic leukemia (CLL) offers the greatest potential. Datamonitor forecasts the three drugs in late-phase development to achieve total sales of $938m in 2019. This stems from the large size of the target patient populations and a lack of effective treatment options in these patient subgroups, which will drive high market penetration. A number of late-phase drugs will have a notable impact on the leukemia market as they go some way towards addressing some of the remaining unmet needs. These agents include Revlimid (lenalidomide; Celgene), RG7159 (obinutuzumab; Glycart/Roche/Genentech/Biogen Idec/Chugai) and bosutinib (PF-5208763; Pfizer). Reasons to Purchase *Justify go/no-go decisions on the basis of potential return on investment *Identifying licensing opportunities based on company portfolio and market needs *Use product profiles to aid pricing and reimbursement decisions [Studien Infos ausblenden] |
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Overview 1 Catalyst 1 Summary 1 ABOUT DATAMONITOR HEALTHCARE 2 About the Oncology pharmaceutical analysis team 2 Executive Summary 3 Strategic scoping and focus 3 Datamonitor insight into the disease market 3 Contributing experts 5 Related reports 5 Upcoming related reports 5 Table of Contents 6 1. Pipeline Overview and Dynamics 7 Key findings 7 Pipeline overview 8 Pipeline summary 8 Acute myeloid leukemia is the form of leukemia most targeted by drug developers 9 Targeted therapies account for over half of leukemia drugs in clinical development 11 Comparative forecasts 12 Drugs in late-phase development for leukemias will achieve combined sales of $1.9 billion by 2019 12 Key companies involved in the leukemias pipeline 14 Novartis 14 Roche 15 Key R&D company strategies 16 Drug developers are targeting increasingly defined subsets of patients 16 2. R&D Approach 17 Key findings 17 Clinical trial design in leukemia 17 Patient selection 17 Increasingly significant in the era of targeted treatment 17 Clinical trial duration 18 Sufficient follow-up is necessary to establish true clinical benefit 18 The advent of novel therapies 18 Diversity of targeted therapies will require an evolution in clinical trial design 18 Clinical trial endpoints in leukemia 18 Most oncology clinical trials designate multiple endpoints 18 Survival 19 Quality of life 19 Response rates 19 Toxicity 19 Time to progression 19 3. Acute lymphoblastic leukemia 21 Key findings 21 Disease overview - market potential 22 Definition of acute lymphoblastic leukemia (ALL) 22 ALL is a group of disorders that result from aberrant proliferation and differentiation of lymphoblasts 22 Genetic alterations provide insight into the pathogenesis of ALL 22 Non-specific syndromes are common in ALL 23 Patient segmentation 23 The classification of ALL is still evolving 23 Patients are stratified according to risk 24 Response to therapy: minimal residual disease is a critical prognostic factor 25 Epidemiology 25 Incidence of ALL will reach over 11,000 in the seven major markets by 2019 25 Current treatment options 27 Remission-induction 31 Consolidation treatment 32 Maintenance treatment 32 Current comparator therapies 33 Unmet need in ALL 33 More effective therapies are required for adult ALL, particularly for relapse 33 Philadelphia chromosome-positive patients remain a patient subset with high unmet need despite new therapies 34 More research is needed for elderly ALL patients 34 Prognostic markers are required for risk-adapted therapeutic strategies 35 Target product profiles versus current level of attainment 35 Induction therapy 35 Relapse therapy 36 Pipeline analysis and forecasts 38 Pipeline summary 38 Comparative forecasts 40 Graspa (erythrocyte-encapsulated L-asparaginase; ERYtech) 42 Drug overview 42 Drug profile 42 Key historical events 43 Clinical trial data 43 Phase II data suggest that Graspa is better tolerated than native L-asparaginase, while inducing similar asparagine depletion 44 SWOT analysis 45 Clinical and commercial attractiveness 45 Limited evidence of clinical efficacy makes it difficult to comment on Graspa's clinical potential 45 A favorable toxicity profile alone may not be sufficient for Graspa to capture significant market share 45 Forecasts to 2019 46 Marqibo (liposomal vincristine; Hana Biosciences) 47 Drug overview 47 Drug profile 47 Key historical events 48 Clinical trial data 49 Marqibo shows promising evidence of efficacy in heavily pretreated ALL 50 SWOT analysis 52 Datamonitor's drug assessment summary for Marqibo 53 Clinical and commercial attractiveness 53 Marqibo will only partially address the need for more effective salvage regimens in ALL 53 Data from a small single-arm study may be insufficient to support approval and drive uptake of Marqibo 54 Forecasts to 2019 54 Rituxan/MabThera (rituximab; Biogen Idec/Roche/Genentech/Zenyaku Kogyo/Chugai) 55 Drug overview 55 Drug profile 56 Key historical events 57 Clinical trial data 58 Rituxan/MabThera plus HyperCVAD shows promising evidence of efficacy in younger patients with CD20-positive ALL 58 Rituxan/MabThera plus HyperCVAD also shows promising efficacy in Burkitt-type ALL, particularly in elderly patients 59 SWOT analysis 61 Datamonitor drug assessment summary for Rituxan 62 Clinical and commercial attractiveness 62 Phase II data point to Rituxan/MabThera's promising potential in ALL, but provoke several questions 62 The use of Rituxan/MabThera in ALL may remain off-label for the foreseeable future 63 Forecasts to 2019 64 4. Acute myeloid leukemia 65 Key findings 65 Disease overview - market potential 66 Definition of acute myeloid leukemia (AML) 66 AML is a disease of older age 66 Symptoms can vary for AML patients 66 Patient segmentation 66 Two classification systems are used in AML 66 Cytogenetics is the most important prognostic factor 67 Age is a major determinant of survival 68 Secondary AML patients have particularly poor prognosis 69 Epidemiology 69 Incidence of AML will reach over 31,000 in the seven major markets by 2019, driven by population aging 69 Current treatment options 71 Induction treatment 73 Post-induction treatment 73 Consolidation treatment 74 Relapse treatment 74 Current comparator therapies 74 Unmet need in AML 75 More effective and tolerable therapies are required for AML, particularly in older patients 75 HSCT remains an underutilized procedure 76 Molecular markers may help improve risk-adapted therapeutic strategies 76 Target product profiles versus current level of attainment 76 Induction therapy 77 Consolidation therapy 77 Relapse therapy 78 Pipeline analysis and forecasts 80 Pipeline summary 80 Comparative forecasts 81 AS1413 (amonafide; Antisoma) 85 Drug overview 85 Drug profile 85 Key historical events 86 Clinical trial data 87 Antisoma has amended the primary endpoint in AS1413's pivotal Phase III study 87 Phase II study shows encouraging evidence of activity in secondary AML 88 SWOT analysis 89 Datamonitor drug assessment summary for AS1413 90 Clinical and commercial attractiveness 90 AS1413 has the potential to address unmet need in a difficult-to-treat patient population 90 AS1413's potential in the wider AML population is uncertain 91 Forecasts to 2019 91 Clolar/Evoltra (clofarabine; Genzyme) 92 Drug overview 92 Drug profile 93 Key historical events 94 Clinical trial data 95 Phase II data in newly diagnosed elderly AML insufficient to support label extension for Clolar 97 Phase II data show potential of Clolar in combination with low-dose cytarabine 98 SWOT analysis 99 Datamonitor drug assessment summary for Clolar/Evoltra 100 Clinical and commercial attractiveness 100 Clolar's unsuccessful bid for accelerated approval in AML is a double blow to Genzyme 100 Clolar could receive off-label use in the absence of label expansion 101 Forecasts to 2019 102 Dacogen (decitabine; Eisai) 103 Drug overview 103 Drug profile 104 Key historical events 105 Clinical trial data 106 Dacogen has shown promising evidence of efficacy in previously untreated elderly AML patients 107 SWOT analysis 109 Datamonitor drug assessment summary for Dacogen 110 Clinical and commercial attractiveness 110 Dacogen's low toxicity could be a major driver of uptake 110 Vidaza will be Dacogen's principal competitor in the AML market 111 Forecasts to 2019 112 Midostaurin (PKC412; Novartis) 113 Drug overview 113 Drug profile 113 Key historical events 114 Clinical trial data 115 Midostaurin shows promising evidence of efficacy in AML patients with wild-type and mutant Flt-3 116 SWOT analysis 117 Datamonitor drug assessment summary for midostaurin 118 Clinical and commercial attractiveness 118 Targeting younger AML patients offers lower commercial potential for midostaurin 118 Novartis's capabilities in niche hematological indications will boost midostaurin's commercial potential 119 Forecasts to 2019 120 PR1 peptide antigen vaccine (The Vaccine Company) 121 Drug overview 121 Drug profile 122 Key historical events 122 Clinical trial data 123 PR1 peptide antigen induced immune and clinical responses in patients with myeloid hematological malignancies in Phase I/II trial 124 SWOT analysis 125 Datamonitor drug assessment summary for PR1 peptide antigen 126 Clinical and commercial attractiveness 126 PR1 peptide antigen could fulfill the unmet need for more tolerable treatment options in elderly AML patients 126 As a therapeutic vaccine, PR-1 peptide antigen will face particular barriers to successful commercialization 127 Forecasts to 2019 127 5. Chronic lymphocytic leukemia 128 Key findings 128 Disease overview - market potential 129 Definition of chronic lymphocytic leukemia (CLL) 129 CLL is an incurable disease characterized by an accumulation of mature B-lymphocytes 129 The definition of CLL has recently changed 130 The etiology of CLL is poorly understood 130 Patient segmentation 131 Rai and Binet staging systems are used to stage CLL 131 Molecular markers are used to identify high-risk patients 132 Epidemiology 133 CLL will remain the most commonly diagnosed leukemia in the seven major markets through to 2019 133 Current treatment options 136 Physicians commonly initiate first-line treatment after a period of observation 137 First-line treatment 138 Second- and third-line treatment 138 Current comparator therapy 138 Rituxan/MabThera (rituximab; Biogen Idec/Genentech/Roche/Chugai/Zenyaku Kogyo) 138 Unmet need in CLL 140 More effective therapies are needed for relapsed and refractory CLL 140 CLL still lacks curative treatment options for the majority of patients 141 More tolerable treatment options are needed for elderly patients 141 Target product profiles versus current level of attainment 142 First-line therapy 142 Second-line therapy 143 Pipeline analysis and forecasts 144 Pipeline summary 144 Comparative forecasts 145 Alvocidib (flavopiridol; Sanofi-Aventis) 148 Drug overview 148 Drug profile 148 Key historical events 149 Clinical trial data 150 Optimization of alvocidib's dosing schedule has reawakened interest in the drug 150 Single-agent alvocidib induces responses in heavily pretreated CLL patients with unfavorable cytogenetics 150 Alvocidib has also shown promise in early stages studies in combination with fludarabine and Rituxan 152 SWOT analysis 153 Datamonitor drug assessment summary for alvocidib 154 Clinical and commercial attractiveness 154 Alvocidib has shown encouraging signs of activity in difficult-to-treat patients 154 Sanofi-Aventis will have to overturn negative perceptions of alvocidib's clinical development in CLL 155 Arzerra could prove to be a major competitor for alvocidib, given its more favorable toxicity profile 155 Forecasts to 2019 156 Revlimid (lenalidomide; Celgene) 157 Drug overview 157 Drug profile 158 Key historical events 159 Clinical trial data 160 Celgene has initiated an extensive clinical development program for Revlimid in CLL 160 Low dose single-agent Revlimid shows promising activity and tolerability in heavily pretreated CLL 161 Early Phase II data show that single-agent Revlimid has favorable toxicity profile in previously untreated elderly CLL 162 Revlimid may be more effective when combined with Rituxan 163 SWOT analysis 164 Datamonitor drug assessment summary for Revlimid 165 Clinical and commercial attractiveness 165 Revlimid has the potential to fill a niche in the CLL market 165 Revlimid's favorable toxicity profile could be an important attribute in the maintenance setting 166 Potential for long-term use could boost Revlimid's commercial potential in CLL 167 Forecasts to 2019 168 RG7159 (obinutuzumab; Glycart/Roche/Genentech/Biogen Idec/Chugai) 169 Drug overview 169 Drug profile 170 Key historical events 171 Clinical trial data 172 There is currently minimal reported evidence of RG7159's clinical efficacy 172 SWOT analysis 173 Datamonitor drug assessment summary for RG7159 174 Clinical and commercial attractiveness 174 Roche has avoided the risk of cannibalizing Rituxan's market share in CLL 174 The design of RG7159's pivotal trial is high-risk, but necessary in order to drive notable uptake 175 Forecasts to 2019 176 6. Chronic myeloid leukemia 177 Key findings 177 Disease overview - market potential 178 Definition of chronic myeloid leukemia (CML) 178 CML is characterized by a single genetic aberration 178 CML patients are commonly asymptomatic at presentation 178 CML has an unknown etiology 178 Patient segmentation 179 CML has a triphasic or biphasic disease course 179 Epidemiology 181 Annual CML incidence will rise to nearly 13,000 in the seven major markets by 2019 181 Improving treatment outcomes will drive significant increases in the prevalence of CML 183 The market potential for newly-diagnosed CML will grow markedly between 2010 and 2019 186 Current treatment options 187 Small molecule Bcr-Abl tyrosine kinase inhibitors dominate the treatment of CML 187 Treatment of newly-diagnosed CML 188 Gleevec-refractory CML 188 Current comparator therapy 188 Gleevec/Glivec (imatinib; Novartis) 188 Unmet need in CML 190 Resistance to Bcr-Abl tyrosine kinase inhibitors is an area of high unmet need 190 Blast crisis lacks effective treatment options but is not a commercially attractive indication 192 Despite good treatment outcomes for the majority of chronic phase patients, there is room for improvement 192 Target product profiles versus current level of attainment 192 Newly diagnosed CML 192 Gleevec refractory/intolerant CML 193 Pipeline analysis and forecasts 195 Pipeline summary 195 Comparative forecasts 197 Bosutinib (PF-5208763; Pfizer) 199 Drug overview 199 Drug profile 200 Key historical events 201 Clinical trial data 201 Bosutinib has shown promising activity and a favorable toxicity profile in Gleevec-resistant/intolerant CML 202 SWOT analysis 204 Datamonitor drug assessment summary for bosutinib 205 Clinical and commercial attractiveness 205 Bosutinib could struggle to penetrate a crowded first-line market ... 205 ...although its promising safety profile could allow Pfizer to position it effectively in the CML market 206 Forecasts to 2019 207 Omapro (omacetaxine mepesuccinate; ChemGenex/Hospira) 209 Drug overview 209 Drug profile 210 Key historical events 211 Clinical trial data 212 Omapro shows promising activity in Gleevec-resistant patients with the T315I mutation but ODAC vote could delay approval 213 Omapro also shows activity in patients refractory/intolerant to at least two tyrosine kinase inhibitors 214 SWOT analysis 215 Datamonitor drug assessment summary for Omapro 216 Clinical and commercial attractiveness 216 Omapro may address one of the largest remaining areas of unmet in CML in the Gleevec era 216 Prospects of approval remain uncertain for Omapro 217 Advances in first-line therapy could threaten Omapro's commercial potential 217 Forecasts to 2019 218 Bibliography 219 Journals 219 Websites 229 Datamonitor reports 232 Other 232 APPENDIX 233 Methodology 233 Datamonitor forecast methodology 233 Epidemiology forecasts 233 Product forecasts 233 Datamonitor drug assessment scorecard 234 Contributing experts 235 About Datamonitor 235 About Datamonitor Healthcare 235 About the Disease analysis team 236 Datamonitor consulting 236 Disclaimer 238 List of Tables Table 1: Drugs in late-phase clinical development for leukemia in the seven major pharmaceutical markets, 2010 9 Table 2: Sales forecasts for drugs in late-phase clinical development for leukemia across the seven major markets, 2010-19 ($m) 12 Table 3: Novartis's portfolio of marketed and pipeline leukemia drugs, 2010 14 Table 4: Roche's portfolio or marketed and pipeline leukemia drugs, 2010 15 Table 5: The French-American-British system for the classification of acute lymphoblastic leukemia (ALL) 23 Table 6: Crude incidence rates of acute lymphoblastic leukemia (ALL) per 100,000 population in the seven major pharmaceutical markets, 2002 26 Table 7: Forecast incidence of acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2002-2019 26 Table 8: Leading agents for acute lymphocytic leukemia (ALL), 2010 29 Table 9: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of adult acute lymphoblastic leukemia (ALL), 2010 36 Table 10: Minimum acceptable product profile (MAPP) and target product profile (TPP) for the treatment of relapsed adult acute lymphoblastic leukemia (ALL), 2010 37 Table 11: Drugs in late-phase clinical development for acute lymphoblastic leukemia (ALL), 2010 38 Table 12: Forecast assumptions for drugs in late-phase clinical development for acute lymphoblastic leukemia (ALL) across the seven major markets, 2010 40 Table 13: Sales forecasts for drugs in late-phase clinical development for acute lymphoblastic leukemia across the seven major markets, 2010-19 ($m) 41 Table 14: Graspa - drug profile, 2010 42 Table 15: Graspa: key historical events, 2004-2010 43 Table 16: Clinical development of Graspa in acute lymphoblastic leukemia (ALL), 2010 43 Table 17: Marqibo - drug profile, 2010 47 Table 18: Marqibo: key historical events, 2000-2010 48 Table 19: Clinical development of Marqibo in acute lymphoblastic leukemia (ALL), 2010 49 Table 20: Sales forecast for Marqibo in acute lymphoblastic leukemia (ALL) across the seven major markets, 2010-19 ($m) 54 Table 21: Rituxan/MabThera - drug profile, 2010 56 Table 22: Rituxan/MabThera: key historical events, 1997-2010 57 Table 23: Clinical development of Rituxan/MabThera in acute lymphoblastic leukemia (ALL), 2010 58 Table 24: Sales forecast for Rituxan in acute lymphoblastic leukemia (ALL) across the seven major markets, 2010-19 ($m) 64 Table 25: French-American-British classification of acute myeloid leukemia (AML) 67 Table 26: Crude incidence rates of acute myeloid leukemia (AML) per 100,000 population in the seven major pharmaceutical markets, 2002 69 Table 27: Forecast incidence of acute myeloid leukemia (AML) in the seven major pharmaceutical markets, 2002-2019 70 Table 28: Leading agents for acute myeloid leukemia (AML), 2010 72 Table 29: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of adult acute myeloid leukemia (AML), 2010 77 Table 30: Minimum acceptable product profile (MAPP) and target product profile (TPP) for consolidation treatment of adult acute myeloid leukemia (AML) in first remission, 2010 78 Table 31: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of adult acute myeloid leukemia (AML), 2010 79 Table 32: Drugs in late-phase clinical development for acute myeloid leukemia (AML), 2010 80 Table 33: Forecast assumptions for drugs in late-phase clinical development for acute myeloid leukemia (AML) across the seven major markets, 2010 (1 of 2) 82 Table 34: Forecast assumptions for drugs in late-phase clinical development for acute myeloid leukemia (AML) across the seven major markets, 2010 (2 of 2) 83 Table 35: Sales forecasts for drugs in late-phase clinical development for acute myeloid leukemia across the seven major markets, 2010-19 ($m) 84 Table 36: AS1413 - drug profile, 2010 85 Table 37: AS1413: key historical events, 2003-2010 86 Table 38: Clinical development of AS1413 in acute myeloid leukemia, 2010 87 Table 39: Sales forecast for AS1413 in acute myeloid leukemia (AML) across the seven major markets, 2010-19 ($m) 91 Table 40: Clolar/Evoltra - drug profile, 2010 93 Table 41: Clolar/Evoltra: key historical events, 1998-2010 94 Table 42: Clinical development of Clolar/Evoltra in acute myeloid leukemia (AML), 2010 95 Table 43: Sales forecast for Clolar/Evoltra in acute myeloid leukemia across the seven major markets, 2010-19 ($m) 102 Table 44: Dacogen - drug profile, 2010 104 Table 45: Dacogen: key historical events, 1999-2010 105 Table 46: Clinical development of Dacogen in acute myeloid leukemia (AML), 2010 106 Table 47: Sales forecast for Dacogen in acute myeloid leukemia (AML) across the seven major markets, 2010-19 ($m) 112 Table 48: Midostaurin - drug profile, 2010 113 Table 49: Midostaurin: key historical events, 2002-2010 114 Table 50: Clinical development of midostaurin in acute myeloid leukemia (AML), 2010 115 Table 51: Sales forecast for midostaurin in acute myeloid leukemia (AML) across the seven major markets, 2010-19 ($m) 120 Table 52: PR1 peptide antigen - drug profile, 2010 122 Table 53: PR1 peptide antigen: key historical events, 1999-2010 122 Table 54: Clinical development of PR1 peptide antigen, 2010 123 Table 55: Sales forecast for PR1 peptide antigen vaccine in acute myeloid leukemia (AML) across the seven major markets, 2010-19 ($m) 127 Table 56: The Rai staging system for chronic lymphocytic leukemia (CLL) 131 Table 57: The Binet staging system for chronic lymphocytic leukemia (CLL) 131 Table 58: Crude incidence rates of chronic lymphocytic leukemia (CLL) per 100,000 population in the seven major pharmaceutical markets, 2002 133 Table 59: Forecast incidence of chronic lymphocytic leukemia (CLL) in the seven major pharmaceutical markets, 2002-2019 134 Table 60: Leading agents for chronic lymphocytic leukemia (CLL), 2010 136 Table 61: Rituxan/MabThera (rituximab) - drug profile, 2010 139 Table 62: Minimum acceptable product profile (MAPP) and target product profile (TPP) for first-line treatment of chronic lymphocytic leukemia (CLL), 2010 142 Table 63: Minimum acceptable product profile (MAPP) and target product profile (TPP) for second-line treatment of chronic lymphocytic leukemia (CLL), 2010 143 Table 64: Drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL), 2010 144 Table 65: Forecast assumptions for drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL) across the seven major markets, 2010 146 Table 66: Sales forecasts for drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL) across the seven major markets, 2010-19 ($m) 147 Table 67: Alvocidib - drug profile, 2010 148 Table 68: Alvocidib: key historical events, 2004-2010 149 Table 69: Clinical development of alvocidib in chronic lymphocytic leukemia (CLL), 2010 150 Table 70: Phase I dose-escalating study of alvocidib in combination with chemotherapy in patients with indolent B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) 152 Table 71: Sales forecast for alvocidib in chronic lymphocytic leukemia (CLL) across the seven major markets, 2010-19 ($m) 156 Table 72: Revlimid - drug profile, 2010 158 Table 73: Revlimid: key historical events, 2005-2010 159 Table 74: Clinical development of Revlimid in chronic lymphocytic leukemia (CLL), 2010 160 Table 75: Sales forecast for Revlimid in chronic lymphocytic leukemia (CLL) across the seven major markets, 2010-19 ($m) 168 Table 76: RG7159 - drug profile, 2010 170 Table 77: RG7159: key historical events, 2007-2010 171 Table 78: Clinical development of RG7159 in chronic lymphocytic leukemia (CLL), 2010 172 Table 79: Sales forecast for RG7159 in chronic lymphocytic leukemia (CLL) across the seven major markets, 2010-19 ($m) 176 Table 80: Different definitions of accelerated phase chronic myeloid leukemia (AP-CML), 2010 179 Table 81: Different definitions of blast crisis chronic myeloid leukemia (BC-CML) 180 Table 82: Crude incidence rates of chronic myeloid leukemia (CML) per 100,000 population in the seven major pharmaceutical markets, 2002 181 Table 83: Forecast incidence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2002-2019 182 Table 84: Forecast prevalence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2010-19 184 Table 85: Number of chronic phase chronic myeloid leukemia (CP-CML) patients in first complete cytogenetic remission (CCyR) receiving a tyrosine kinase inhibitor in the seven major markets, 2010-19 186 Table 86: Leading agents for chronic myeloid leukemia (CML), 2010 187 Table 87: Gleevec (imatinib; Novartis) - drug profile, 2010 189 Table 88: Number of chronic myeloid leukemia (CML) patients developing Gleevec resistance in the seven major pharmaceutical markets, 2010-19 191 Table 89: Minimum acceptable product profile (MAPP) and target product profile (TPP) for treatment of newly diagnosed chronic phase chronic myeloid leukemia (CP-CML), 2010 193 Table 90: Minimum acceptable product profile (MAPP) and target product profile (TPP) treatment of Gleevec-refractory/intolerant chronic phase chronic myeloid leukemia (CP-CML), 2010 194 Table 91: Drugs in late-phase clinical development for chronic myeloid leukemia (CML), 2010 195 Table 92: Forecast assumptions for drugs in late-phase clinical development for chronic myeloid leukemia (CML) across the seven major markets, 2010 197 Table 93: Sales forecasts for drugs in late-phase clinical development for chronic myeloid leukemia (CML) across the seven major markets, 2010-19 ($m) 198 Table 94: Bosutinib - drug profile, 2010 200 Table 95: Bosutinib: key historical events, 2006-2010 201 Table 96: Clinical development of bosutinib in chronic myeloid leukemia (CML), 2010 201 Table 97: Sales forecast for bosutinib in chronic myeloid leukemia (CML) across the seven major markets, 2010-19 ($m) 208 Table 98: Omapro - drug profile, 2010 210 Table 99: Omapro: key historical events, 2004-2010 211 Table 100: Clinical development of Omapro in chronic myeloid leukemia (CML), 2010 212 Table 101: Sales forecast for Omapro in chronic myeloid leukemia (CML) across the seven major markets, 2010-19 ($m) 218 Table 102: Datamonitor drug assessment parameters 234 List of Figures Figure 1: Number of drugs in clinical development for the four principal subtypes of leukemia, by phase of development, 2010 10 Figure 2: Number of drugs in clinical development for leukemia, by phase of development and class, 2010 11 Figure 3: Forecast incidence of acute lymphoblastic leukemia (ALL) in the seven major pharmaceutical markets, 2010-19 27 Figure 4: Summary of unmet needs in acute lymphoblastic leukemia (ALL), 2010 33 Figure 5: Datamonitor drug assessment for drugs in late-phase clinical development for acute lymphoblastic leukemia (ALL), 2010 39 Figure 6: Summary of data from GRASPALL Phase II study of Graspa in relapsed acute lymphoblastic leukemia (ALL) 44 Figure 7: Graspa - SWOT analysis in acute lymphoblastic leukemia (ALL), 2010 45 Figure 8: Summary of data from rALLy Phase II study of Marqibo in relapsed acute lymphoblastic leukemia (ALL) 50 Figure 9: Summary of data from Phase I/II study of Marqibo in relapsed/refractory acute lymphoblastic leukemia (ALL) 51 Figure 10: Marqibo - SWOT analysis in acute lymphoblastic leukemia (ALL), 2010 52 Figure 11: Datamonitor drug assessment summary for Marqibo in acute lymphoblastic leukemia (ALL), 2010 53 Figure 12: Summary of data from Phase II study of Rituxan/MabThera in newly-diagnosed Philadelphia chromosome-negative, CD20-positive precursor B-cell acute lymphoblastic leukemia (ALL) 59 Figure 13: Summary of data from Phase II study of Rituxan/MabThera in newly-diagnosed Burkitt-type acute lymphoblastic leukemia (ALL)/Burkitt lymphoma 60 Figure 14: Rituxan/MabThera - SWOT analysis in acute lymphoblastic leukemia (ALL), 2010 61 Figure 15: Datamonitor drug assessment summary for Rituxan in acute lymphoblastic leukemia (ALL), 2010 62 Figure 16: Forecast incidence of acute myeloid leukemia (AML) in the seven major pharmaceutical markets, 2010-19 71 Figure 17: Summary of unmet needs in acute myeloid leukemia (AML), 2010 75 Figure 18: Datamonitor drug assessment for drugs in late-phase clinical development for acute myeloid leukemia (AML), 2010 81 Figure 19: Summary of data from Phase II study of AS1413 in secondary acute myeloid leukemia (AML) 88 Figure 20: AS1413 - SWOT analysis in acute myeloid leukemia (AML), 2010 89 Figure 21: Datamonitor drug assessment summary for AS1413 in acute myeloid leukemia (AML), 2010 90 Figure 22: Summary of preliminary data from the 'CLASSIC II' Phase II study of Clolar/Evoltra in newly-diagnosed elderly acute myeloid leukemia (AML) patients 97 Figure 23: Summary of preliminary data from a Phase II study of Clolar/Evoltra in combination with low-dose cytarabine in newly-diagnosed elderly acute myeloid leukemia (AML) patients 98 Figure 24: Clolar/Evoltra - SWOT analysis in acute myeloid leukemia (AML), 2010 99 Figure 25: Datamonitor drug assessment summary for Clolar/Evoltra in acute myeloid leukemia (AML), 2010 100 Figure 26: Summary of data from Phase II trial of Dacogen in previously untreated elderly acute myeloid leukemia (AML) patients 107 Figure 27: Summary of data from a multicenter Phase II trial of Dacogen in previously untreated elderly acute myeloid leukemia (AML) patients 108 Figure 28: Dacogen - SWOT analysis in acute myeloid leukemia (AML), 2010 109 Figure 29: Datamonitor drug assessment summary for Dacogen in acute myeloid leukemia (AML), 2010 110 Figure 30: Summary of data from Phase Ib study of midostaurin in newly-diagnosed acute myeloid leukemia (AML) 116 Figure 31: Midostaurin - SWOT analysis in acute myeloid leukemia (AML), 2010 117 Figure 32: Datamonitor drug assessment summary for midostaurin in acute myeloid leukemia (AML), 2010 118 Figure 33: Phase I/II trial results investigating PR1 peptide antigen in mixed myeloid hematological malignancies 124 Figure 34: PR1 peptide antigen - SWOT analysis in acute myeloid leukemia (AML), 2010 125 Figure 35: Datamonitor drug assessment summary for PR1 peptide antigen in acute myeloid leukemia (AML), 2010 126 Figure 36: Characteristic immunophenotype of accumulating malignant B-lymphocytes in chronic lymphocytic leukemia (CLL) 129 Figure 37: Forecast incidence of chronic lymphocytic leukemia (CLL) in the seven major pharmaceutical markets, 2010-19 135 Figure 38: Summary of unmet needs in chronic lymphocytic leukemia (CLL), 2010 140 Figure 39: Datamonitor drug assessment for drugs in late-phase clinical development for chronic lymphocytic leukemia (CLL), 2010 145 Figure 40: Summary of data from Phase II clinical trial of alvocidib in relapsed/refractory chronic lymphocytic leukemia (CLL) 151 Figure 41: Alvocidib - SWOT analysis in chronic lymphocytic leukemia (CLL), 2010 153 Figure 42: Datamonitor drug assessment summary for alvocidib in chronic lymphocytic leukemia (CLL), 2010 154 Figure 43: Phase II study of Revlimid in relapsed/refractory chronic lymphocytic leukemia (CLL), 161 Figure 44: Preliminary data from Phase II study of Revlimid as first-line treatment in elderly chronic lymphocytic leukemia (CLL) patients 162 Figure 45: Preliminary data from Phase II trial of Revlimid plus Rituxan in relapsed/refractory chronic lymphocytic leukemia (CLL) 163 Figure 46: Revlimid - SWOT analysis in chronic lymphocytic leukemia (CLL), 2010 164 Figure 47: Datamonitor drug assessment summary for Revlimid in chronic lymphocytic leukemia (CLL), 2010 165 Figure 48: RG7159 - SWOT analysis in chronic lymphocytic leukemia (CLL), 2010 173 Figure 49: Datamonitor drug assessment summary for RG7159 in chronic lymphocytic leukemia (CLL), 2010 174 Figure 50: Forecast incidence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2010-19 183 Figure 51: Forecast prevalence of chronic myeloid leukemia (CML) in the seven major pharmaceutical markets, 2010-19 185 Figure 52: Summary of unmet needs in chronic lymphocytic leukemia (CML), 2010 190 Figure 53: Datamonitor drug assessment for drugs in late-phase clinical development for chronic myeloid leukemia (CML), 2010 196 Figure 54: Phase II study of bosutinib in Gleevec-resistant/intolerant chronic myeloid leukemia (CML) in chronic phase 202 Figure 55: Phase II study of bosutinib in Gleevec-resistant/intolerant chronic myeloid leukemia (CML) in accelerated phase or blast crisis 203 Figure 56: Bosutinib - SWOT analysis in chronic myeloid leukemia (CML), 2010 204 Figure 57: Datamonitor drug assessment summary for bosutinib in chronic myeloid leukemia (CML), 2010 205 Figure 58: Study 202: Interim data from Phase II/III study of Omapro in Gleevec-resistant chronic myeloid leukemia (CML) patients with the T315I mutation 213 Figure 59: Study 203: Interim data from Phase II/III study of Omapro in chronic myeloid leukemia (CML) patients resistant/intolerant to at least two tyrosine kinase inhibitors 214 Figure 60: Omapro - SWOT analysis in chronic myeloid leukemia (CML), 2010 215 Figure 61: Datamonitor drug assessment summary for Omapro in chronic myeloid leukemia (CML), 2010 216 [Inhaltsverzeichnis ausblenden] |
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