FDA Approves Acalabrutinib + Venetoclax Combo for First-Line CLL Treatment

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The FDA has approved the combination of oral acalabrutinib (Calquence) and venetoclax (Venclexta) for the first-line treatment of adults with chronic lymphocytic leukemia (CLL), including small lymphocytic lymphoma. This all-oral, fixed-duration regimen was shown in the phase 3 AMPLIFY study to provide better progression-free survival and safety compared to investigator's choice of chemoimmunotherapy.

Why it matters

CLL is one of the most common forms of leukemia in adults, and while outcomes have improved in recent years, patients often face long treatment durations and ongoing disease management challenges. This new fixed-duration, all-oral regimen provides an important new option for eligible patients to achieve durable responses in the first-line setting.

The details

In the AMPLIFY study, previously untreated adults with CLL without del(17p) or TP53 mutation were randomized to receive the acalabrutinib + venetoclax combination, the combination plus obinutuzumab, or investigator's choice of chemoimmunotherapy. Patients in the acalabrutinib + venetoclax arms were treated for 14 28-day cycles, while chemoimmunotherapy was administered for 6 cycles. At a median follow-up of 42.6 months, median progression-free survival was not estimable in the acalabrutinib + venetoclax arms compared to 47.6 months in the chemoimmunotherapy arm.

• The FDA approval was based on findings from the global, open-label, phase 3 AMPLIFY study.
• Patients in the acalabrutinib + venetoclax arms were treated for 14 28-day cycles.
• Chemoimmunotherapy was administered for six cycles.
• At a median follow-up of 42.6 months, median progression-free survival was assessed.
• At a median follow-up of 41.0 months, deaths were evaluated.

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