6 May 2025 - Approval based on ECHO Phase III trial results which demonstrated over 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the European Union for the treatment of adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous stem cell transplant.