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（acalabrutinib）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 Malignancies Second primary malignancies, including non-skin carcinomas, have occurred in 11% of patients with hematologic malignancies treated with CALQUENCE monotherapy in the combined safety database of 612 patients. The most frequent second primary malignancy was skin cancer, reported in 7% of patients. Advise protection from sun exposure. Atrial Fibrillation and Flutter In the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy, atrial fibrillation and atrial flutter of any grade occurred in 3% of patients, and Grade 3 in 1% of patients. Monitor for atrial fibrillation and atrial flutter and manage as appropriate. ADVERSE REACTIONS The most common adverse reactions (≥20%) of any grade were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%). *Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions. The most common Grade ≥ 3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%). Dosage reductions or discontinuations due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively. Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 4.8% of patients. DRUG INTERACTIONS Strong CYP3A Inhibitors: Avoid co-administration with a strong CYP3A inhibitor. If a strong CYP3A inhibitor will be used short-term, interrupt CALQUENCE. Moderate CYP3A Inhibitors: When CALQUENCE is co-administered with a moderate CYP3A inhibitor, reduce CALQUENCE dose to 100 mg once daily. Strong CYP3A Inducers: Avoid co-administration with a strong CYP3A inducer. If a strong CYP3A inducer cannot be avoided, increase the CALQUENCE dose to 200 mg twice daily. Gastric Acid Reducing Agents: If treatment with a gastric acid reducing agent is required, consider using an H2-receptor antagonist or an antacid. Take CALQUENCE 2 hours before taking an H2-receptor antagonist. Separate dosing with an antacid by at least 2 hours. Avoid co-administration with proton pump inhibitors. Due to the long-lasting effect of proton pump inhibitors, separation of doses may not eliminate the interaction with CALQUENCE. SPECIFIC POPULATIONS There is insufficient clinical data on CALQUENCE use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus. It is not known if CALQUENCE is present in human milk. Advise lactating women not to breastfeed while taking CALQUENCE and for at least 2 weeks after the final dose. About CALQUENCE® (acalabrutinib) CALQUENCE (acalabrutinib, previously known as ACP-196) is an inhibitor of Bruton tyrosine kinase (BTK). CALQUENCE binds covalently to BTK, thereby inhibiting its activity.1 In B cells, BTK signaling results in activation of pathways necessary for B cell proliferation, trafficking, chemotaxis, and adhesion. The recommended dose of CALQUENCE is one 100mg capsule taken orally approximately every twelve hours until disease progression or unacceptable toxicity.1 CALQUENCE may be taken with or without food. Acalabrutinib is also in development for the treatment of multiple B-cell malignancies and other cancers including chronic lymphocytic leukemia, MCL, Waldenström macroglobulinemia, follicular lymphoma, diffuse large B-cell lymphoma, and multiple myeloma. It is also being studied as a monotherapy and in combination trials for the treatment of solid tumors. More than 35 clinical trials across 40 countries with more than 2,500 patients are underway or have completed. CALQUENCE was granted Orphan Drug Designation for the treatment of adult patients with MCL in September 2015 and Breakthrough Therapy Designation in August 2017 by the US FDA for the treatment of adult patients with MCL who have received at least one prior therapy.  About Mantle Cell Lymphoma (MCL) MCL is an aggressive B-cell non-Hodgkin lymphoma (NHL) with poor prognosis.6,7,8,9 MCL accounts for approximately 3% of new NHL cases in the US, with approximately 3,300 new cases diagnosed each year.10,11 The median age at diagnosis is 68 years, with a 3:1 male predominance.7 While MCL patients initially respond to treatment, there is a high relapse rate. About the ACE-LY-004 trial ACE-LY-004 is a Phase II open-label, single-arm clinical trial in 124 adult patients with relapsed or refractory MCL. The trial showed that 80% (95% CI: 72, 87) of patients treated with CALQUENCE achieved an overall response; 40% (95% CI: 31, 49) achieved a complete response and 40% (95% CI: 32, 50) achieved a partial response, per 2014 Lugano classification as assessed by Independent Review Committee. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583076.htm