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Chronic Lymphocytic Leukemia: Off-Label Prescribing Drives Market Growth

Decision Resources, Inc., March 2010, Pages: 48


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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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