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Venetoclax Approved for CLL

Published: 2019-06-17 |

Source: National Cancer Institute

On May 15, 2019, the Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the initial treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

"This is the second chemotherapy-free regimen now approved for the first-line treatment of CLL, and the first such regimen that is given for a limited duration," said Milos Miljikovic, M.D., who studies CLL in NCI's Center for Cancer Research. The combination of venetoclax and obinutuzumab is given in 12 four-week cycles. The other FDA-approved treatment for CLL and SLL that does not involve chemotherapy is ibrutinib (Imbruvical). Patients receiving this drug take it until the disease progresses or the side effects become unmanageable.

Venetoclax, a pill, blocks the action of a protein called BCL2, which helps keep cancer cells alive. Obinutuzumab, a monoclonal antibody that is injected intravenously, targets a protein called CD20, which frequently found on the surface of tumor cells in patients with certain types of leukemias.

Participants who received venetoclax plus obinutuzumab were 67% less likely to have the disease worsen, or to die than those who received chlorambucil plus obinutuzumab. The overall response rate was 85% in the venetoclax-plus-obinutuzumab group and 71% in the chlorambucil-plus-obinutuzumab group.

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