U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL...
AbbVie Inc. (ABBV)
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Source: PR Newswire
First all-oral, fixed-duration combination regimen approved for previously untreated patients with CLL Approval supported by data from the Phase 3 AMPLIFY trialRegimen offers another option for the potential of time off treatment, marking a meaningful advance in long-term disease managementNORTH CHICAGO, Ill., Feb. 20, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). The approval is supported by data from the Phase 3 AMPLIFY trial.1This milestone updates the treatment of CLL in the first-line setting, establishing the VENCLEXTA and acalabrutinib combination as the first and only all-oral, fixed-duration regimen for previously untreated patients. The regimen supports current standards of care by offering pa
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ABBV
Earnings
- 2/4/26 - Miss
ABBV
Sec Filings
- 2/20/26 - Form 4
- 2/20/26 - Form 4
- 2/20/26 - Form 4
- ABBV's page on the SEC website