AbbVie Files to Move Venclexta Combo Into the CLL Front Line

AbbVie files to move Venclexta combo into the CLL front line

AbbVie has filed for FDA approval of a new front-line therapy for chronic lymphocytic leukaemia that it thinks could be 'practice changing."

AbbVie seeks FDA approval for all-oral venetoclax-acalabrutinib combo in untreated CLL

AbbVie has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for the combination of VENCLEXTA (venetoclax) and acalabrutinib as an all-oral, fixed-duration treatment regimen for patients with previously untreated chronic lymphocytic leukemia (CLL). The submission is supported by data from the Phase 3 AMPLIFY trial.The AMPLIFY trial, sponsored by AstraZeneca, compared VENCLEXTA plus acalabrutinib—with or witho…

Venclexta Treatment Combo is Being Reviewed by FDA For CLL

AbbVie submitted a supplemental new drug application for Venclexta plus Calquence treatment in previously untreated chronic lymphocytic leukemia.

FDA Review Underway for Oral Venetoclax, Acalabrutinib Combo in Untreated CLL

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sNDA Submitted to FDA for Venetoclax Plus Acalabrutinib in Untreated CLL

AMPLIFY trial results form the basis of the submission, with venetoclax/acalabrutinib showing a PFS advantage vs chemoimmunotherapy in patients with CLL.