Calquence approved in Japan to treat relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma)-AstraZeneca

AstraZeneca’s Calquence (acalabrutinib), a next-generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma [SLL). The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ASCEND Phase III trial and a Phase I trial in Japanese patients, showing Calquence monotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus a standard treatment of rituximab, a monoclonal antibody, combined with the physician’s choice of idelalisib, a PI3-kinase inhibitor or bendamustine, a chemotherapy. In the ASCEND trial, Calquence reduced the risk of disease progression or death by 69% (hazard ratio, 0.31; 95% confidence interval, 0.20-0.49, p<0.0001). these results were published in journal of clinical oncology in 2020. see- ghia p, et al." ascend: phase iii, randomized trial of acalabrutinib versus idelalisib plus rituximab or bendamustine plus rituximab in relapsed or refractory chronic lymphocytic leukemia [published online ahead of print, 2020 may 27]. j clin oncol. 2020; jco1903355. doi:10.1200 jco.19.03355.>