Europe’s CHMP Conditionally Approves Venetoclax for Chronic Lymphocytic Leukemia

Europe’s Committee for Medicinal Products for Human Use conditionally approved venetoclax for adult patients with chronic lymphocytic leukemia who have failed chemoimmunotherapy and a B-cell receptor pathway inhibitor and for those with del17p or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor.

If approved, venetoclax would become the first BCL-2 inhibitor approved in Europe.

The European Medicines Agency grants conditional marketing authorization to medicines in the interest of public health where the benefit of its immediate availability to patients outweighs the risk due to the need for additional data.

Sources: Reuters, October 14, 2016; PRNewswire, October 14, 2016.