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Today (August 28), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) stated,AstraZeneca's submission of the marketing application for Acalabrutinib Maleate tablets has been accepted.Public information shows that acalabrutinib (generic name:Acalabrutinib Capsules) is aBruton's Tyrosine Kinase (BTK) Inhibitor, which has previously been approved for two indications in China.According to the pipeline information on AstraZeneca's official website, it is speculated that the new indication for which AstraZeneca's acalabrutinib has applied for marketing authorization this time may beFirst-line treatment for chronic lymphocytic leukemia (CLL)。
Screenshot source:CDE Official Website
Acalabrutinib is a new generation of highly selective, original BTK inhibitor that inhibits its activity by covalently binding to BTK. In B cells, BTK signaling leads to the activation of pathways required for B-cell proliferation, trafficking, chemotaxis, and adhesion. In China,AcalabrutinibFirst approved for marketing in March 2023, for the treatment ofAdult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy; The second indication was approved in September 2023.，Monotherapy is indicated for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior therapy.。
In April this year, AstraZeneca announced that in aPhase 3 ChangE Clinical Trial Led by ChinaIn China,AcalabrutinibShowsPatients with untreated chronic lymphocytic leukemia (CLL)PFS benefit with statistical and clinical significance. ChangE is a randomized, multi-center, open-label Phase III clinical trial led by China, with 66% of the patients from China (including Taiwan, China). The trial aims to evaluate the safety and efficacy of acalabrutinib compared with chlorambucil plus rituximab in previously untreated CLL patients.The main results of the ChangE clinical trial showed that acalabrutinib reached its primary endpoint, demonstrating superiority compared to the combination regimen of chlorambucil and rituximab.Statistically significant and clinically meaningful improvement in progression-free survival (PFS) was observed across all pre-specified subgroups.. The trial also showed a trend toward improved overall survival (OS) benefit compared with the combination of chlorambucil and rituximab.
AstraZeneca previously stated in a press release that the ChangE results further confirm the advantages of acalabrutinib as a monotherapy compared to the current standard treatment for chronic lymphocytic leukemia in China.ChangE and the positive results from the global Phase 3 ELEVATE-TN trial, previously conducted in a broad population of patients with chronic lymphocytic leukemia, will lay the foundation for submission to Chinese regulators later this year.
Chronic Lymphocytic Leukemia (CLL) is the most common type of chronic leukemia in adults. In CLL, too many hematopoietic stem cells in the bone marrow become abnormal lymphocytes, which are difficult to fight infections. As the number of abnormal cells increases, the space for healthy white blood cells, red blood cells, and platelets decreases. This can lead to anemia, infections, and bleeding. B-cell receptor signaling through BTK is one of the key growth pathways in CLL.Notably, on an international scale, in July this year, AstraZeneca announced positive interim results from the Phase III clinical trial AMPLIFY.In the study, acalabrutinib was combined with venetoclax, with or without obinutuzumab, inTreatment-Naive Adult Patients with Chronic Lymphocytic Leukemia (CLL)In China, compared with standard chemimmunotherapy, it significantly improved progression-free survival (PFS) in patients, with statistical significance and clinical importance.Looking forward to more good news, bringing new treatment options to more patients with chronic lymphocytic leukemia.
References:
[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 28, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c
[2]In the ChangE Phase III clinical trial led in China, Calquence demonstrated statistically and clinically significant progression-free survival benefits for untreated chronic lymphocytic leukemia patients. Retrieved Apr 26, 2024, from https://www.astrazeneca.com.cn/zh/media/press-releases/2024/04-25-01.html
[3] AstraZeneca Official Website Pipeline. Retrieved July 25， 2024, From https://www.astrazeneca.com/our-therapy-areas/pipeline.html
[4] A New Indication for Konkqi®, a Next-Generation Highly Selective BTK Inhibitor, Approved in China: Monotherapy for Adult Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Have Received at Least One Prior Treatment. Retrieved Sep 4， 2023, from https://mp.weixin.qq.com/s/U6X-1Dp9ChPZHxEQuHz9XQ
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