European Commission Approves AbbVie’s Venclyxto for Lymphocytic Leukemia

The European Commission approved AbbVie’s Venclyxto (venetoclax) in combination with obinutuzumab to treat adults with chronic lymphocytic leukemia (CLL) who were previously untreated.

The approval was based on the results of a phase 3 clinical trial, which demonstrated progression-free survival in patients treated with Venclyxto plus obinutuzumab compared to patients who received a standard of care chemotherapy regimen of chlorambucil plus obinutuzumab.

The approval is the third for the drug. Venclyxto is approved in more than 50 countries, including the U.S.