FDA Approves Genentech’s Venclexta® Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Business Wire
– First and only all-oral, fixed-duration regimen designed to provide CLL patients with the potential to experience time off treatment –– Approval expands Genentech’s fixed-duration portfolio by providing eligible first-line patients another option alongside the established Venclexta plus Gazyva regimen – SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the combination regimen of Venclexta® (venetoclax) plus acalabrutinib for the treatment of previously untreated adults with chronic lymphocytic leukemia (CLL), based on results from the Phase III AMPLIFY study.“Today’s approval represents an important step forward for people newly diagnosed with chronic lymphocytic leukemia,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “As the first and only all-oral, fixed-duration regimen, this approval gi
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