Acalabrutinib Receives Approval for Treatment-Naïve Chronic Lymphocytic Leukemia in Japan

The Japanese approval of acalabrutinib for the treatment of patients with treatment-naïve chronic lymphocytic leukemia was supported by data from the phase 3 ELEVATE-TN trial.

The Japanese Ministry of Health, Labor, and Welfare has approved acalabrutinib (Calquence) for the treatment of adult patients with treatment-naïve chronic lymphocytic leukemia (CLL), according to a press release from AstraZeneca.1

The approval of acalabrutinib in Japan was supported by findings from 2 clinical trials, including the phase 3 ELEVATE-TN trial (NCT02475681), which compared acalabrutinib on its own or with obinutuzumab (Gazyva) vs obinutuzumab with chlorambucil in patients with CLL. With a median follow-up of 58.2 months, investigators of the ELEVATE-TN trial indicated that acalabrutinib with or without obinutuzumab significantly improved progression-free survival compared with chlorambucil plus obinutuzumab. Additionally, acalabrutinib yielded an 89% reduction in the risk of death or disease progression in combination with obinutuzumab (HR, 0.11; 95% CI, 0.07-0.16) and a 79% reduction as monotherapy compared with chlorambucil plus obinutuzumab (HR, 0.21; 95% CI, 0.15-0.30).

Findings from a phase 1 trial further supported the approval of acalabrutinib. The study included Japanese patients with treatment-naïve CLL. Findings from the trial highlighted an overall response rate of 88.9% (95% CI, 63.2-98.8%) and 100% (95% CI, 66.4%-100%) for patients treated with acalabrutinib monotherapy and in combination with obinutuzumab, respectively.

“Results from ELEVATE-TN and our local Japanese trial confirm that [acalabrutinib] provides a significant improvement in progression-free survival compared with chemotherapy-based combination of chlorambucil and obinutuzumab for patients with treatment-naïve chronic lymphocytic leukemia,” Koji Izutsu, MD, PhD, head of department of Hematology of the National Cancer Center Hospital in Tokyo, Japan, said in the press release. “Today’s approval marks great progress for physicians and patients in Japan, as they can now be treated with [acalabrutinib] earlier in their treatment journey.”

Previously, the FDA approved acalabrutinib tablets across all CLL indications in addition to small lymphocytic leukemia and relapsed/refractory mantle cell lymphoma in August 2022.2 The FDA based its approval on the ELEVATE-PLUS trials, 3 open-label phase 1 studies that indicated that acalabrutinib tablets demonstrated comparable efficacy and safety as capsule formulations.


  1. Calquence approved in Japan for adults with treatment-naïve chronic lymphocytic leukaemia. News release. AstraZeneca. December 28, 2022. Accessed January 4, 2023.
  2. Calquence tablet formulation approved in the US across current indications. News Release. AstraZeneca. August 5, 2022. Accessed January 3, 2023.