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.