东盟制药
阿卡替尼 Acaluni (Acalabrutinib) 2022年8月2日，经老挝卫生部食品药品司（FDD）批准，东盟制药（TLPH）生产的阿卡替尼Acaluni (Acalabrutinib）正式获准在老挝上市。此次获批的阿卡替尼，商品名为Acaluni，胶囊剂，规格为100mg/粒，60粒/瓶。
阿卡替尼 Acaluni (Acalabrutinib) 2022年8月2日，经老挝卫生部食品药品司（FDD）批准，东盟制药（TLPH）生产的阿卡替尼Acaluni (Acalabrutinib）正式获准在老挝上市。此次获批的阿卡替尼，商品名为Acaluni，胶囊剂，规格为100mg/粒，60粒/瓶。
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Acalabrutinib, also known as Acalabrutinib, is an oral BTK inhibitor under AstraZeneca. In October 2017 , after being granted breakthrough therapy and accelerated approval, acalabrutinib was approved by the FDA for marketing for patients with mantle cell lymphoma who had previously received other therapies; in 2019 , based on the Phase III clinical studies ELEVATE-TN and ASCEND , acalabrutinib was approved for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) .
In 2020 , at the 25th Annual Meeting of the European Hematology Association (EHA), the 4-year overall remission rate (ORR) of acalabrutinib as a first-line monotherapy for the treatment of chronic lymphocytic leukemia (CLL) in patients with newly diagnosed CLL was as high as 97% ( 7% for complete remission and 90% for partial remission) , and the 18-month survival rate of patients with relapsed/refractory CLL was as high as 82%, and it showed good long-term safety .
CLL is one of the most common types of leukemia in adults. Age is one of the risk factors for this disease, and it is most common in people over 60 years old. Since CLL progresses slowly, long-term, safe and effective treatment will greatly improve the patient's quality of life, help alleviate symptoms, and prevent possible complications. Acalabrutinib effectively meets the above requirements and is therefore chosen by many patients.
BTK is an important target for the treatment of hematological malignancies. So far, there are three BTK inhibitors on the market worldwide, namely ibrutinib, acalabrutinib and zanubrutinib.
Clinical data show that the first-generation ibrutinib has long-term efficacy in patients with newly diagnosed, relapsed/refractory (RR) and del(17p) high-risk CLL. However, some CLL patients experience some adverse effects after receiving ibrutinib treatment, such as fatigue, joint pain, arrhythmia, hypertension and increased risk of bleeding.
As a second-generation BTK inhibitor, the biggest feature of acalabrutinib is that it has lower toxicity and high specificity. Clinical data show that acalabrutinib not only has higher safety, but also proves that it can provide meaningful and long-term clinical benefits for patients with first-line, relapsed or refractory disease, providing patients with a new treatment option.
Currently, acalabrutinib is being developed for a variety of B-cell blood tumors, including CLL, SLL, MCL, diffuse large B-cell lymphoma and other malignancies, and its growth momentum continues to be strong.
Acalabrutinib, trade name Acaluni, capsules, specifications are 100 mg/capsule, 60 capsules/bottle.
