Japan Approves AstraZeneca’s Calquence for Leukemia

AstraZeneca’s Calquence (acalabrutinib) has received approval from Japan’s Ministry of Health, Labor and Welfare for treating chronic lymphocytic leukemia (CLL).

The approval allows the drug’s use in adult patients with relapsed or refractory CLL, including small lymphocytic lymphoma. It has been approved for the same indication in the U.S.

The drugmaker said the Japanese approval was based on positive results from two studies that showed the Bruton's tyrosine kinase inhibitor provided a statistically significant improvement in progression-free survival compared to a standard treatment of rituximab, a monoclonal antibody, alongside either the PI3-kinase inhibitor idelalisib or the chemotherapy drug bendamustine.