2017年10月31日,美国（FDA）加速批准acalabrutinib(商品名 Calquence 美国AstraZeneca制药 LP)为套细胞淋巴瘤成年治疗患者曽接受至少一种以前治疗。
FDA的肿瘤卓越中心主任和FDA的药品评价和研究中心中血液学和肿瘤产品办公室代理主任Richard Pazdur，M.D.说：“套细胞淋巴瘤是一种特别地侵袭性癌症，” “对患者对治疗无反应或已复发，在初始研究中Calquence提供一种新治疗选择曽显示对有些患者显示反应的高率。”
套细胞淋巴瘤罕见和快速生长类型的非-何杰金氏淋巴瘤和，按照在美国卫生院国立癌症研究所，代表在美国所有非-何杰金氏淋巴瘤病例的3至10%。套细胞淋巴瘤是淋巴系统，是机体免疫系统的部分的一种癌症，和是由淋巴组织，淋巴结，脾脏，胸腺，扁桃腺和骨髓组成。至套细胞淋巴瘤被诊断时，它通常已播散至淋巴结，骨髓和其他器官。
Calquence是一种激酶抑制剂通过阻断癌症繁殖和传播所需的一种酶起作用。
Calquence利用加速批准途径，被批准，在此下FDA课批准对严重情况药物其中有医疗迫切需求而且一个药物显示有某种效应有理由可能预测患者的临床益处。被要求进一步研究证实和描述Calquence的预期临床益处和承办单位当前正在进行这种试验。
今天的批准是根据来自一项单-臂试验的数据包括124例有套细胞淋巴瘤患者，患者已接受至少一种以前治疗。该试验测量许多患者他们的肿瘤在治疗后如何经历完全或部分缩小(总体反应率)。在试验中，81%患者有一个完全或部分缓解(完全缓解40 %，部分缓解41%)。
Calquence的常见副作用包括头痛；腹泻；瘀伤；疲乏和肌肉痛；和贫血，血中血小板减少和中性细胞减少。
严重副作用包括出血，感染和房颤。另外癌症，有些用Calquence患者中曽发生已知为第二个原发性恶性病。正在哺乳喂养妇女不应用Calquence因为它可能致危害至新生婴儿。
FDA授权这个申请优先审评和突破性治疗指定。Calquence还接受孤儿药物指定，它提供奖励帮助和鼓励为罕见疾病药物的开发。
Calquence包装规格为100毫克*60粒/瓶强度胶囊
FDA授权Calquence的加速批准至AstraZeneca制药 LP.
CALQUENCE® (acalabrutinib) Approved for Previously-Treated Mantle Cell Lymphoma, Available for Order at Biologics, Inc
Accelerated approval of Bruton tyrosine kinase (BTK) inhibitor in MCL marks AstraZeneca’s entry into the treatment of blood cancers
80% of patients receiving CALQUENCE achieved an overall response, with 40% achieving a complete response
IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE
Hemorrhage
Serious hemorrhagic events, including fatal events, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Grade 3 or higher bleeding events, including gastrointestinal, intracranial, and epistaxis, have been reported in 2% of patients. Overall, bleeding events, including bruising and petechiae of any grade, occurred in approximately 50% of patients with hematological malignancies.
The mechanism for the bleeding events is not well understood.
CALQUENCE may further increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies, and patients should be monitored for signs of bleeding.
Consider the benefit-risk of withholding CALQUENCE for 3 to 7 days pre- and post-surgery, depending upon the type of surgery and the risk of bleeding.
Infection
Serious infections (bacterial, viral, or fungal), including fatal events and opportunistic infections, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Grade 3 or higher infections occurred in 18% of these patients. The most frequently reported Grade 3 or 4 infection was pneumonia. Infections due to hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML) have occurred.
Monitor patients for signs and symptoms of infection and treat as medically appropriate. Consider prophylaxis in patients who are at increased risk for opportunistic infections.
Cytopenias
In the combined safety database of 612 patients with hematologic malignancies, patients treated with CALQUENCE monotherapy experienced Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (11%), and thrombocytopenia (8%), based on laboratory measurements. Monitor complete blood counts monthly during treatment.
Second Primary Malign |
