FDA Approves Genentech's Venclexta And Acalabrutinib Combo For Untreated CLL

(RTTNews) - Genentech, a member of the Roche Holding AG (RHHBY), said on Friday that the U.S. Food and Drug Administration has approved the combination of Venclexta plus acalabrutinib for the treatment of previously untreated adults with chronic lymphocytic leukemia (CLL).

The approval was based on results from the Phase III AMPLIFY study which showed that the combination regimen reduced the risk of disease progression or death by 35% versus chemoimmunotherapy.

Venclexta is already approved for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination regimens for newly diagnosed AML patients aged 75 or older, or those ineligible for standard chemotherapy.

Venclexta is developed by AbbVie and Genentech, and is jointly commercialized in the United States and marketed by AbbVie outside the U.S.