Beijing News (Reporter Wang Kala) Recently, the National Medical Products Administration (NMPA) announced that AstraZeneca's acalabrutinib capsule (Chinese trade name: Kang Keqi) has been approved by the NMPA for listing in China. It is indicated as monotherapy for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). This marks the third indication for acalabrutinib in China, indicating its application in both previously untreated and treated CLL/SLL patients.
CLL/SLL is a mature B lymphocyte clonal proliferative tumor, characterized by the accumulation of lymphocytes in peripheral blood, bone marrow, spleen, and lymph nodes. It is also the most common type of leukemia in adults in Western countries. The annual incidence rate in Europe and America is (4-5)/100,000, while the incidence in Asian populations is one-tenth that of Europe and America. The median age of onset in Europe and America is 70-75 years, whereas in China, the median age of onset is 65 years.
This approval was based on the positive results of the ChangE Phase III clinical trial. The ChangE study showed that, compared with the combination treatment of chlorambucil and rituximab (C+R), acalabrutinib reduced the risk of disease progression or death by 92% in previously untreated CLL patients, demonstrating a statistically significant difference and clear clinical significance. The median PFS (progression-free survival) and the 24-month PFS rate for acalabrutinib were both improved compared to the C+R group. In all predefined subgroups, including those associated with poor prognosis, the progression-free survival in the acalabrutinib treatment group showed significant improvement over the C+R group. The efficacy results of the Chinese subgroup were consistent with the overall study population. The trial also indicated a trend toward improved overall survival in previously untreated CLL patients receiving acalabrutinib compared to the C+R group. Relevant data were presented at the 66th American Society of Hematology (ASH) Annual Meeting held in December 2024.
Proofread by Wang Xin