Analyst Outlook
Venetoclax (AbbVie/Roche) is a novel B-cell lymphoma-2 (BCL-2) inhibitor currently being developed
for treatment-naïve and relapsed/refractory chronic lymphocytic leukemia (CLL). In May 2015, Roche
announced that the US Food and Drug Administration (FDA) had granted breakthrough therapy
designation for venetoclax in 17p deletion relapsed/refractory CLL (Roche press release, 2015). Early
clinical trials highlighted safety concerns after a patient death due to tumor lysis syndrome (AbbVie
press release, 2015b; Roberts et al., 2015). However, AbbVie/Roche have since modified the treatment
protocol, and no severe events of tumor lysis syndrome have occurred following this.
Drug Overview
Venetoclax is an inhibitor of the BCL-2 family of proteins. This family of proteins is responsible for the
regulation of cell death by either inducing or inhibiting apoptosis (Cory and Adams, 2002). Increased
expression of BCL-2 can lead to resistance to apoptosis in cancer cells. Venetoclax blocks the function
of the BCL-2 protein, leading to an increase in pro-apoptotic proteins and restoration of normal
apoptosis regulation (Souers et al., 2013).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 venetoclax : Chronic lymphocytic leukemia
LIST OF FIGURES
9 Figure 1: Venetoclax for chronic lymphocytic leukemia – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary for venetoclax in chronic
lymphocytic leukemia
10 Figure 3: Datamonitor Healthcare’s drug assessment summary for venetoclax in chronic
lymphocytic leukemia
LIST OF TABLES
4 Table 1: Venetoclax drug profile
7 Table 2: Venetoclax Phase III and pivotal trial data in chronic lymphocytic leukemia
8 Table 3: Overview of ongoing Phase II trials for venetoclax in chronic lymphocytic leukemia
8 Table 4: Overview of Phase I data for venetoclax in chronic lymphocytic leukemia