Fixed-duration acalabrutinib + venetoclax ± obinutuzumab receives positive opinion from CHMP for adults with previously untreated CLL

On April 29, 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion and recommendation for the approval of a fixed-duration regimen of acalabrutinib, a highly selective Bruton’s tyrosine kinase inhibitor (BTKi), in combination with venetoclax, with or without obinutuzumab, for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL).¹ 

This positive opinion is based on results from the phase III AMPLIFY trial (NCT03836261), which were previously reported by the Lymphoma Hub. Briefly, acalabrutinib plus venetoclax was associated with a 35% reduction in the risk of disease progression or death vs standard of care chemoimmunotherapy, while acalabrutinib plus venetoclax and obinutuzumab was associated with a 58% reduction in the risk of disease progression or death.¹ Median progression-free survival was not reached in either experimental arm vs 47.6 months in the chemoimmunotherapy arm.¹ The safety profile of acalabrutinib was consistent with its known safety profile, with no new safety signals.¹