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Chronic Lymphocytic Leukemia: Off-Label Prescribing Drives Market Growth
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Description: |
The chronic lymphocytic leukemia (CLL) market is relatively small compared with other cancer markets, yet untapped opportunities exist for companies that can cure the disease or that offer remission-inducing therapies with improved toxicity. Furthermore, the CLL market has the potential to afford companies special marketing protections, such as orphan disease status. Despite the presence of heavy off-label physician prescribing (in particular, for Biogen Idec/Genentech/Roche’s recently approved Rituxan [rituximab]) that is driving current market growth, incentives still exist for companies to seek regulatory approval for their drugs in development for CLL; indeed, although CLL is a small market, it is the third largest hematological malignancy in the United States after non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM)
Questions Answered in this Report
- Despite the presence of many approved drugs to treat CLL (including the recently approved Rituxan), offlabel prescribing of certain agents continues to help drive the CLL market. What are the most commonly prescribed off-label CLL drugs? Is reimbursement a challenge in CLL off-label prescribing?
- The small CLL patient population in 2008 is not expected to drastically grow by the year 2018. What are Decision Resources’ epidemiology estimates and projections? What factor will be the largest contributor to the increase in incidence of CLL?
- Surveyed hematological-oncologists rely heavily on biological markers to determine a CLL patient’s prognosis. Which markers do the majority of surveyed hematological-oncologists rely on to assist in the prognosis of CLL?
- More than 40 confirmed agents are in clinical development for CLL. Are there novel drug classes within the CLL clinical pipeline? Are any late-stage therapies currently approved in other indications, and are they already being prescribed off-label in CLL?
Scope
- Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
- Primary research: A January 2010 survey of 50 U.S. hematological-oncologists covering topics such as the most common CLL symptoms, biological markers used for CLL prognosis, and current and emerging CLL therapies.
- Epidemiology: Newly diagnosed incident, prevalent diagnosed, and treatable pool first-line or relapsed/ refractory cases of CLL.
- Emerging therapies: Phase I: 9 drugs; Phase I/II: 8 drugs; Phase II: 6 drugs; Phase III: 4 drugs.
- Graphics: 19 figures and 5 tables.
Key Terms for this Report:
Alvocidib, Arzerra, Blood cancers, Chronic lymphocytic leukemia, CLL, Fludara, Genasense, Hematological cancers, Leukeran, Off-label prescribing, Orphan drug status, Revlimid, Rituxan, Stemcell therapy, Treanda |
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Contents: |
Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
CLL—Disease Overview
Etiology and Pathophysiology
Diagnosis and Classifi cation
Symptoms
Role of Biological Markers in Progression
Epidemiology
Disease Definition
Patient Population
Newly Diagnosed Incident Cases
Prevalent Cases
Staging
Current Therapies for CLL
Recent Approvals
Biogen Idec/Genentech/Roche’s Rituxan (Rituximab)
GlaxoSmithKline/Genmab’s Arzerra (Ofatumumab)
Cephalon’s Treanda (Bendamustine)
Established Single-Agent Therapies
Genzyme/Bayer’s Campath (Alemtuzumab)
GlaxoSmithKline’s Leukeran (Chlorambucil)
Genzyme/Bayer’s Fludara (Fludarabine)
Side Effects, Drug Resistance, and Other Therapies
Treatment After First-Line Therapy: Single-Agents and Combination Therapies
Off-Label Prescribing in CLL
Side Effects of CLL Therapies
Elderly and Genetically High-Risk CLL Patient Therapies
Stem Cell Transplantation: A Potential Cure for CLL?
Emerging Therapies for CLL
Genta’s Genasense (Oblimersen)
Sanofi -Aventis’s Alvocidib
Celgene’s Revlimid (Lenalidomide)
2008 Statistics and CLL Market Outlook
CLL Market Drivers and Constraints
Regulatory Advantages: Fast-Track and Orphan Status
Therapy Cost: Are Higher Prices of New Therapies an Issue in CLL?
CLL Clinical Pipeline Is Robust, but Challenges Remain
Bibliography
Tables
1. Common Staging Systems Used in the Treatment of CLL
2. Current Treatment Options for CLL
3. NCI Definition of Response to Treatment in CLL Patients
4. Select Emerging Therapies for the Treatment of CLL, 2010
5. Total, Worldwide Sales of Select Drugs to Treat CLL, 2008
6. Snapshot of Select CLL Emerging Therapies in Late-Stage Development
Figures
1. Survey Question: What Percentage of Your CLL Patients Experience the Following Symptoms?
2. Survey Question: In What Percentage of Your CLL Patients, if Any, Do You Use the Following Biological Markers to Determine CLL Prognosis?
3. Number of Incident, Diagnosed Cases of CLL in the United States, Europe, and Japan, 2008-2018
4. Number of Prevalent, Diagnosed Cases of CLL in the United States, Europe, and Japan, 2008-2018
5. Treatable Pool of First-Line or Relapsed/Refractory CLL Cases in the United States, Europe, and Japan (Combined), 2008-2018
6. Survey Question: Which of These Statements Regarding Rituxan (Rituximab) Use for CLL Do You Agree With?
7. Survey Question: Which of These Statements Regarding Arzerra’s (Ofatumumab) Recent Approval by the FDA for CLL Refractory Disease Do You Agree With?
8. Survey Question: Which of These Statements Regarding Treanda (Bendamustine) Do You Agree With?
9. Survey Question: What Percentages of Your CLL Patients Move to/Add on a Second-Line Therapy Within the Following Time Frames?
10. Survey Question: Among Your CLL Patients That Proceed to Second-Line Therapy (Whether Switching or in Addition to First-Line Therapy), in What Percentage of Patients Do the Following Factors Trigger the Move to Second Line?
11. Survey Question: Which of These Statements Regarding Campath (Alemtuzumab) for CLL Do You Agree With?
12. Survey Question: Which of the Following Agents (Currently Not Approved for CLL)Would You Consider Prescribing (if Approved) or Do You Already Prescribe?
13. Survey Question: How Many of Your CLL Patients Suffer from These Side Effects As a Direct Result of Treatment?
14. Survey Question: What Percentage of Your CLL Patients Receive the Following Supportive Treatments Currently, or at Any Stage in the Course of Their Disease?
15. Survey Question: For the Elderly with CLL, and Those Who Are Less Able to Tolerate Toxicities, Which of the Following Agents Do You Prescribe or What Agents Would You Consider Prescribing If They Were Approved?
16. Survey Question: For High-Risk CLL Patients (deleted 17p), Which of the Following Agents Would You Consider Prescribing (If Approved) or Do You Already Prescribe?
17. Survey Question: Which of These Statements Regarding Genasense (Oblimersen) for CLL Do You Agree With?
18. Survey Question: Which of These Statements Regarding Alvocidib for CLL Do You Agree With?
19. Survey Question: Which of These Statements Regarding Revlimid (Lenalidomide) for CLL Do You Agree With? |
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Companies Mentioned |
- Abbott Laboratories
- Advancell
- Aegera Therapeutics
- Alexion Pharmaceuticals
- Amgen
- Ascenta
- AstraZeneca
- Baxter
- Bayer
- BioCryst Pharmaceuticals
- Biogen Idec
- Bristol-Myers Squibb
- BTG
- Celgene
- Centocor
- Cephalon
- Eleos
- Eli Lilly
- Enzon Pharmaceuticals
- Facet Biotech
- Fresenius Biotech
- Gemin X Pharmaceuticals
- Genentech
- Genmab
- Genzyme
- Geron
- GlaxoSmithKline
- Hospira
- Immunomedics
- Laboratoire Francais du Fractionnement et des Biotechnologies
- Mayo Clinic
- Medarex
- Memgen
- MethylGene
- Mitsui Norin
- Mundipharma
- Novartis
- Ortho-Biotech
- Pfizer
- Polyphenon Pharma
- Sanofi -Aventis
- Santaris Pharma
- Seattle Genetics
- Serono
- SuperGen
- Taiho
- Takeda
- The Leukemia & Lymphoma Society
- Trubion Pharmaceuticals
- XOMA |
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