The US Food and Drug Administration (FDA) has approved a new drug Venclexta (venetoclax) to treat chronic lymphocytic leukaemia (CLL) in patients with a specific chromosomal abnormality.
Designed to help restore a cell’s ability to self-destruct, Venclexta is manufactured by AbbVie, and marketed by AbbVie and Genentech USA.
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CLL is one of the most common types of leukaemia in adults and it is caused by the progressive accumulation of abnormal lymphocytes, a type of white blood cell.
The drug is said to be the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein.
This oral, once-daily medicine selectively inhibits the BCL-2 protein, which blocks apoptosis (programmed cell death) of cells, including some cancer cells, and can be over expressed in CLL cells.
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Venclexta is indicated for daily use after detection of 17p deletion.
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By GlobalDataThe 17p deletion is found in three to 10% of previously untreated cases and up to 30-50% of relapsed or refractory cases.
The deletion is a genomic alteration, in which a part of chromosome 17 is absent. Patients with this mutation typically have a poor prognosis and a life expectancy of less than two to three years.
AbbVie CEO Richard Gonzalez said: "The FDA’s approval of Venclexta marks a major milestone for our company, and more importantly for the patients diagnosed with relapsed / refractory CLL who harbour the 17p deletion.
"BCL-2 inhibition is a novel mechanism that brings a new treatment option to patients who need additional therapies."
The efficacy of Venclexta was evaluated in a single-arm clinical trial, in which 106 patients with CLL who have a 17p deletion had received at least one prior therapy.
Venclexta clinical trial programme principal clinical investigator Matthew S. Davids said: "Results from the clinical trial programme show that Venclexta provides significant overall response among previously treated patients with CLL with 17p deletion."
