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Venclexta

  • ID: 4775404
  • Report
  • January 2019
  • Region: Global
  • 45 pages
  • Datamonitor Healthcare
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Drug Overview
Venclexta (venetoclax; AbbVie/Roche) is an inhibitor of the B-cell lymphoma-2 (BCL-2) family of proteins. This family of proteins is responsible for the regulation of cell death by either inducing or inhibiting apoptosis. Increased expression of BCL-2 can lead to resistance to apoptosis in cancer cells. Venclexta blocks the function of the BCL-2 protein, leading to an increase in pro-apoptotic proteins and restoration of normal apoptosis regulation.

Analyst Outlook
Venclexta (venetoclax; AbbVie/Roche) is a novel B-cell lymphoma 2 (BCL-2) inhibitor that received an accelerated US Food and Drug Administration (FDA) approval for the second-line treatment of chronic lymphocytic leukemia (CLL) patients with deletion of the short arm of chromosome 17 (17p deletion) in April 2016. Venclexta was subsequently given marketing authorization from the European Medicines Agency (EMA) to treat the same patient population in December 2016. The drug’s initial commercial potential was limited due to the small size of the target population given that 17p deletion CLL represents less than 10% of newly diagnosed CLL patients. In addition, the potential approval of Acerta and AstraZeneca’s Calquence (acalabrutinib) may threaten Venclexta’s market position as the developers are planning to file for approval for high-risk relapsed/refractory CLL in 2019. However, Venclexta has since been approved for use in the general relapsed/refractory CLL population, and AbbVie and Roche will be looking to maximize the drug’s commercial potential by pursuing label expansions to include all CLL patients in the first-line setting.
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OVERVIEW
Drug Overview
Product Profiles
Venclexta: Chronic lymphocytic leukaemia (CLL)
Venclexta: Multiple myelomas
Venclexta: Acute myeloid leukaemia (AML)

LIST OF FIGURES
Figure 1: The author's drug assessment summary of Venclexta for CLL
Figure 2: Venclexta sales for CLL across the US and five major EU markets, by country, 2017–26
Figure 3: Venclexta for multiple myeloma – SWOT analysis
Figure 4: The author's drug assessment summary for Venclexta in multiple myeloma
Figure 5: Venclexta sales for multiple myeloma across the US, Japan, and five major EU markets, by country, 2017–26
Figure 6: Venclexta for acute myeloid leukaemia – SWOT analysis
Figure 7: The author's drug assessment summary of Venclexta for acute myeloid leukaemia

LIST OF TABLES
Table 1: Venclexta drug profile
Table 2: Approval history of Venclexta for CLL in the US, Japan, and five major EU markets
Table 3: Trials of Venclexta for CLL
Table 4: Venclexta for CLL – SWOT analysis
Table 5: Venclexta drug profile
Table 6: Venclexta Phase III trial in multiple myeloma
Table 7: Venclexta early-phase data in multiple myeloma
Table 8: Venclexta early-phase trials in multiple myeloma
Table 9: Venclexta sales for multiple myeloma across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 10: Patients treated with Venclexta in the US, Japan, and five major EU markets, by country, 2017–26
Table 11: Venclexta drug profile
Table 12: Venclexta Phase III trials in acute myeloid leukaemia
Table 13: Venclexta early-phase data in acute myeloid leukaemia

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