US EditionFDA Approves Genentech’s Venclexta® Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia
FDA approves the first all-oral, fixed-duration Venclexta and acalabrutinib regimen for untreated chronic lymphocytic leukemia, reducing disease progression risk by 35%, based on Phase III AMPLIFY data.
- The FDA granted approval on Feb. 20, 2026, for VENCLEXTA and acalabrutinib as the first all‑oral, fixed‑duration regimen for previously untreated adults with CLL.
- The AMPLIFY Phase 3 trial, sponsored by AstraZeneca, compared Venclexta plus acalabrutinib with or without obinutuzumab against chemoimmunotherapy using a fixed 14-cycle schedule with Venclexta starting in cycle 3 and a 5-week ramp-up.
- At a median follow-up of 42.6 months, AMPLIFY showed the combination reduced the risk of disease progression or death by 35% versus chemoimmunotherapy.
- Clinical monitoring is advised because serious reactions in patients receiving Venclexta plus acalabrutinib included COVID‑19 , second primary malignancies , neutropenia , and tumor lysis syndrome incidence 0.3%.
- Companies noted that Genentech and AbbVie will jointly commercialize the regimen, with Genentech offering patient support services and helpline 866‑4ACCESS.
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FDA OKs Novel Fixed-Duration Oral Combo for Untreated CLL
(MedPage Today) -- The FDA approved acalabrutinib (Calquence) plus venetoclax (Venclexta) for previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma as the first all-oral, fixed-duration regimen in the frontline setting...
U.S. Food and Drug Administration (FDA) Approves Combination Treatment of VENCLEXTA® (venetoclax) and Acalabrutinib for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
First all-oral, fixed-duration combination regimen approved for previously untreated patients with CLLApproval 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 management
Genentech, the American subsidiary of Roche, has obtained approval from the US Food and Drug Administration (FDA) for a treatment for chronic lymphocytic leukemia (CLL).
AstraZeneca Secures US Approval For Fixed-duration Calquence Regimen In CLL
AstraZeneca plc (LON:AZN) Calquence (acalabrutinib) in combination with venetoclax has been approved in the US as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The approval by the US Food and Drug Administration (FDA) was based on positive results from the AMPLIFY Phase III trial, which were presented at the American Society of Hematol…
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