EMA approves acalabrutinib combination for patients with previously untreated MCL

On May 6, 2025, the European Medicines Agency (EMA) granted approval to acalabrutinib, a second-generation, selective Bruton’s tyrosine kinase inhibitor (BTKi), in combination with bendamustine and rituximab, for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT).¹

This approval was based on results from the randomized, multicenter, phase III ECHO trial (NCT02972840), which were previously reported by the Lymphoma Hub.¹ Briefly, the median progression-free survival among patients treated with acalabrutinib in combination with bendamustine and rituximab was 66.4 months vs 49.6 months in patients treated with standard-of-care chemoimmunotherapy alone.¹ The addition of acalabrutinib to bendamustine and rituximab  reduced the risk of disease progression or death by 27%.¹ The safety profile of acalabrutinib was consistent with its known safety profile, with no new safety signals reported.¹ 

Acalabrutinib in combination with chemoimmunotherapy was also previously approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated MCL.¹