The drug manufactured by AbbVie Inc. of North Chicago, Illinois, is called Venclexta (venetoclax) and is for the treatment of patients with CLL who have a genetic abnormality called 17p deletion and who have been treated with a least one prior therapy.
The effectiveness of Venclexta was tested in small clinical trial of 106 CLL patients previously treated and who also had 17p deletion. Trial participants took Venclexta orally every day, beginning with 20 mg dose and increased the dose over a five-week period to 400 mg. Results showed that 80 percent of trial participants experienced a complete or partial remission of their cancer.
CLL is characterized by the progressive accumulation of abnormal white blood cells, which can result in swollen lymph nodes, fever, infection, abnormal bleeding and fatigue. Patients with CLL who have a 17p deletion lack a portion of the chromosome that acts to prevent cancer growth. CLL patients with this abnormal chromosome make up about 10 percent of of the 15,000 new patients in the U.S. each year with untreated CLL and in approximately 20 percent of patients with relapsed CLL.
The most common side effects of Venclexta include low white blood cell count (neutropenia), diarrhea, nausea, anemia, upper respiratory tract infection, low platelet count (thrombocytopenia) and fatigue.
Venclexta’s application for approval had been granted FDA expedited review through the agency’s breakthrough therapy designation and priority review programs. Venclexta also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.
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