Calquence granted extension of approval by MHLW in Japan for treatment-naïve chronic lymphocytic leukaemia (including small lymphocytic lymphoma)

Calquence was previously approved in Japan for the treatment of adults with relapsed or refractory CLL.

The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on positive results from two clinical trials, including the ELEVATE-TN Phase III trial in adults with treatment-naïve CLL. This trial showed that Calquence combined with obinutuzumab or as monotherapy demonstrated a significantly improved progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab. Data from the interim analysis of ELEVATE-TN was published in The Lancet in 2020. Additionally, a Phase I trial in treatment-naïve Japanese patients with CLL was also submitted to MHLW supporting the approval, with the trial showing an overall response rate of 88.9% (95% CI: 63.2, 98.8%) for Calquence alone and 100% (95% CI: 66.4, 100%) for Calquence combined with obinutuzumab.

CLL is the most prevalent type of adult leukaemia across the globe but is considered a rare disease in Japan and East Asia, with fewer than one person newly diagnosed per 100,000 persons per year across Japan.

See-"Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzumab for treatment-naive chronic lymphocytic leukaemia (ELEVATE-TN): a randomised, controlled, phase III trial";Jeff P Sharman, MD,Miklos Egyed, MD, Prof Wojciech Jurczak, MD ,Alan Skarbnik, MD, John M Pagel, MD,Ian W Flinn, MD et al. Published:April 18, 2020DOI:https://doi.org/10.1016/S0140-6736(20)30262-2.