AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients

The submission is supported by positive results from the Phase 3 AMPLIFY trial

AbbVie has submitted a supplemental New Drug Application (sNDA) to the USFDA for a fixed-duration, all-oral combination of Venclexta  (venetoclax) and acalabrutinib for previously untreated chronic lymphocytic leukemia (CLL) patients.

The submission is supported by positive results from the Phase 3 AMPLIFY trial, where the combination significantly improved progression-free survival compared to standard chemoimmunotherapy.2

"This submission could mark a shift in frontline CLL treatment, offering patients a time-limited oral option," said Svetlana Kobina, vice president, global medical affairs, oncology, AbbVie.