Abstract
Acalabrutinib is a second generation Bruton's tyrosine kinase inhibitor and was recently approved in the treatment of chronic lymphocytic leukaemia. We undertook a systematic review and meta‐analysis of randomised controlled trials to determine the risks of acalabrutinib‐related second primary malignancies (SPM) and nonmelanoma skin cancers (NMSC). The incidence of SPM was 4.7% higher in the acalabrutinib arm compared to control arm with risk ratio (RR) of 1.76 (5.32 vs 3.2 per 100 person‐years). Notably, NMSC was the most common SPM, and the incidence was 2.56 per 100 person‐years in the acalabrutinib group versus 1.12 per 100 person‐years in the control group (RR 2.43). Long‐term follow‐up and future studies are necessary to define the actual relationship and their risk factors.
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