Abbott's companion diagnostic for Venclexta gains FDA approval

13 April 2016
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The companion diagnostic for chronic lymphocytic leukemia (CLL) treatment Venclexta (venetoclax) has received approval a day after the drug itself was given the green light by the US Food and Drug Administration (FDA).

On Monday, accelerated approval was given to the drug for CLL patients who have a chromosomal abnormality called 17p deletion, and who have been treated with at least one prior therapy.

The first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is over-expressed in many patients with CLL, it has been developed by US drugmaker AbbVie (NYSE: ABBV) with Swiss pharma giant Roche (ROG: SIX) and its subsidiary Genentech.

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