2017年11月9日，FDA宣布将加速批准阿斯利康（AstraZeneca）治疗已接受过一种优先治疗方案套细胞淋巴瘤（mantle cell lymphoma，MCL）患者的药物Calquence（acalabrutinib）。Calquence是一个激酶抑制剂，FDA在早前已授予该药物的优先审评资格、突破性疗法认定和孤儿药资格。
套细胞淋巴瘤是一种罕见且生长快速的非霍奇金淋巴瘤。根据美国国家癌症研究所（NCI）的统计，套细胞淋巴瘤病例占美国所有非霍奇金淋巴瘤病例的3%至10%。套细胞淋巴瘤是一种淋巴系统癌症，当被诊断出来时，往往已经扩散至淋巴结或骨髓等器官。对于MCL患者还存在巨大的未被满足的医疗需求。
Calquence是一款Bruton酪氨酸激酶（BTK）抑制剂，能阻断癌细胞用于增殖和扩散所需的酶。为MCL患者带来治疗的希望。在一项涉及124名MCL患者的单臂试验中，评估了Calquence治疗后的完全缓解及部分缓解的患者比例。结果显示，81%的患者对Calquence的治疗相应，其中40%完全缓解，41%部分缓解。FDA基于这一优异的疗效数据，加速批准了该药物的上市。
FDA药物评估与研究中心的血液和肿瘤学产品办公室代理主任、肿瘤学卓越中心主任Richard Pazdur博士说：“MCL是一种具有侵袭性的癌症。对于那些接受先前治疗而没有获得缓解或疾病复发的患者而言，Calquence提供了一种新的治疗方案。”

CALQUENCE(acalabrutinib Capsules)
CALQUENCE Rx
Generic Name and Formulations:
Acalabrutinib 100mg; caps.
Company:
AstraZeneca Pharmaceuticals
Indications for CALQUENCE:
Mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
Adult:
Swallow whole with water. 100mg approx. every 12hrs until disease progression or unacceptable toxicity. Concomitant moderate CYP3A inhibitors: 100mg once daily. Concomitant strong CYP3A inducers: avoid; if needed, increase dose to 200mg twice daily. Dose modifications for adverse reactions: see full labeling.
Children:
Not established.
Warnings/Precautions:
Risk of hemorrhage; consider the benefit/risk of withholding treatment for 3–7 days pre-and post-surgery. Monitor for infections; consider prophylaxis if at risk for opportunistic infections. Monitor for cytopenias; obtain CBCs monthly. Risk of second primary malignancies (eg, skin cancer or other carcinomas); advise patients to protect from sun exposure. Monitor for atrial fibrillation/flutter; manage appropriately. Pregnancy: avoid. Nursing mothers: not recommended (during and for at least 2 weeks after final dose).
Interactions:
See Adult. Avoid concomitant strong CYP3A inhibitors (eg, itraconazole); if short-term use (eg, anti-infectives for ≤7days), interrupt acalabrutinib therapy. Concomitant moderate CYP3A inhibitors: reduce acalabrutinib dose (see Adult). Avoid concomitant strong CYP3A inducers (eg, rifampin); if unavoidable, increase acalabrutinib dose (see Adult). Increased risk of hemorrhage with concomitant antiplatelets or anticoagulants; monitor. Antagonized by gastric acid reducing agents (eg, PPI (avoid), H2-receptor antagonist, or antacid); if needed, consider ranitidine, famotidine, or calcium carbonate. Separate dosing by at least 2hrs with antacids. Take acalabrutinib 2hrs before H2-receptor antagonist use.
Pharmacological Class:
Bruton’s tyrosine kinase (BTK) inhibitor.
Adverse Reactions:
Anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, bruising; hemorrhage, infections, second primary malignancy, atrial fibrillation/flutter.
Generic Availability:
NO
How Supplied:
Caps—60