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AbbVie Submits for U.S. FDA Approval of Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL)
AbbVie (NYSE: ABBV) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib in previously untreated patients with CLL, offering CLL patients another VENCLEXTA combination regimen with the potential for time-limited treatment.The submission is based on the positive results from the Phase 3 AMPLIFY trial.1 The combination regimen of VENCLEX
About this update from Abbvie Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"Combination therapy has potential to be an all-oral, fixed-duration regimen for previously untreated patients with CLL ","length":118,"tagName":"p"}]},{"val":[{"type":"text","content":"Application is supported by data from the Phase 3 AMPLIFY trial that showed statistically significant improvement in progression-free survival vs chemoimmunotherapy","length":164,"tagName":"p"}]},{"val":[{"type":"text","content":"Regimen offers an opportunity for patients to take time off treatment, an important step toward improved disease management","length":123,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":405,"olType":false},{"type":"text","content":"NORTH CHICAGO, Ill., July 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib in previously untreated patients with CLL, offering CLL patients another VENCLEXTA combination regimen with the potential for time-limited treatment.The submission is based on the positive results from the Phase 3 AMPLIFY trial.1 The combination regimen of VENCLEXTA and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL.2","length":708,"tagName":"p"},{"type":"text","content":""This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of VENCLEXTA and acalabrutinib for previously untreated patients with chronic blood cancer. This new fixed-treatment duration approach could allow patients the opportunity for time off treatment, if approved, and be potentially practice-changing in frontline CLL care," said Svetlana Kobina, vice president, global medical affairs, oncology, AbbVie.","length":483,"tagName":"p"},{"type":"text","content":"About the AMPLIFY StudyAMPLIFY is an AstraZeneca-sponsored, global, multi-center Phase 3 trial evaluating VENCLEXTA plus acalabrutinib alone or combined with obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without del(17p) or TP53 mutation.1","length":305,"tagName":"p"},{"type":"text","content":"Data presented a...