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Venclexta® Approved for Chronic Lymphocytic Leukemia

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The United States Food and Drug Administration (FDA) has approved the targeted agent, Venclexta (venetoclax), for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a specific chromosomal abnormality, referred to as a 17p deletion. Patients must have received at least one prior therapeutic regimen before starting treatment with Venclexta.
Chronic lymphocytic leukemia is the most common form of adult leukemia. The American Cancer Society estimates that approximately 15,000 people will be diagnosed with CLL this year. Currently, there are approximately 95,000 people in the United States living with CLL.
CLL is characterized by the production of atypical lymphocytes. Lymphocytes are specialized immune cells that exist in two forms: B- and T-cells. These cells are produced in the bone marrow and each serves a specific function in aiding the body to fight infection. The large majority of CLL cases involve mature B-lymphocytes that tend to live much longer than normal. B-lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. This results in overcrowding of these areas and suppression of the formation and function of blood and immune cells. Additionally, the cancerous lymphocytes themselves do not function normally, leading to a further reduction in the body’s ability to fight infection.
CLL is diagnosed most commonly in elderly patients (65 years or greater). Since these patients are often unable to tolerate the aggressive therapies compared to their younger counterparts due to additional medical conditions and/or differences in the metabolizing of the agents, the toxicity of treatment is an important issue.
The BCL-2 protein is a type of protein that contributes to a cancer cell’s survival. Overexpression of the BCL-2 protein in CLL cells is associated with increased survival time of the cancer cells as well as resistance to standard chemotherapy. Venclexta is an agent that binds to the BCL-2 protein, thereby disabling its ability to keep cancer cells alive.
The approval of Venclexta was based on results of a clinical trial that included 106 patients with CLL with a 17p deletion. The patients had received at least one prior therapy.
Patients on the trial were treated with Venclexta daily for 5 weeks.
• 80% of patients achieved a partial or complete disappearance of detectable cancer when treated with Venclexta.
• The most common side effects associated with Venclexta were low levels of blood cells, diarrhea and nausea.
In the FDA news release announcing the approval of Venclexta, Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research stated, “For certain patients with CLL who have not had favorable outcomes with other therapies, Venclexta may provide a new option for their specific condition.”
Reference: United States Food and Drug Administration. FDA News Release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm495253.htm. Accessed April 13, 2016.