The US Food and Drug Administration has approved acalabrutinib with bendamustine and rituximab for treating adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). Clinical evidence The safety and efficacy of this combination therapy were evaluated in a clinical trial involving 598 patients with untreated MCL aged 65 years or older and who were not candidates for HSCT.
The combination of acalabrutinib, bendamustine, and rituximab achieved a progression-free survival of 66.4 months compared to 49.6 months in the placebo plus bendamustine and rituximab group. Dosage and administration Available as tablets 100 mg orally approximately every 12 hours with water and with or without food Contraindications – None Warnings and precautions Serious and opportunistic infections Hemorrhage Cytopenias Second primary…