AstraZeneca has secured a key approval for its BTK inhibitor Calquence in Europe, which the company has said could be a blockbuster new indication for the drug.

阿斯利康的BTK抑制剂Calquence已在欧洲获得关键批准，该公司表示这可能成为该药物的一个重磅新适应症。

The European Commission has cleared a fixed-duration regimen of Calquence (acalabrutinib) in combination with AbbVie/Roche's BCL-2 inhibitor Venclexta (venetoclax) – with or without Roche's anti-CD20 drug Gazyva (obinutuzumab) – for previously untreated adult patients with CLL.

欧盟委员会已经批准了Calquence（acalabrutinib）与AbbVie/Roche的BCL-2抑制剂Venclexta（venetoclax）联合使用的一个固定疗程方案——无论是否联合Roche的抗CD20药物Gazyva（obinutuzumab）——用于既往未接受治疗的成年CLL患者。

The regimen provides a new first-line treatment option 'that may help to minimise long-term side effects and reduce drug resistance as they may occur with continuous treatment,' according to Barbara Eichhorst of University Hospital Cologne, the lead investigator in the

该方案提供了一种新的首选治疗选择，“可以最大限度地减少长期副作用，并降低可能因持续治疗而产生的耐药性，”科隆大学医院的首席研究员芭芭拉·艾希霍斯特表示。

AMPLIFY

放大

study that underpinned the EU approval.

支撑欧盟批准的那项研究。

'A fixed-duration regimen is appealing to patients and helps with adherence during the treatment period,' she added.

“固定疗程对患者很有吸引力，并有助于在治疗期间坚持下去，”她补充道。

AMPLIFY compared the Calquence-based therapy to a chemoimmunotherapy (CIT) regimen of fludarabine, cyclophosphamide, and rituximab (FCR) or bendamustine plus rituximab, depending on the age of the patient.

AMPLIFY 将基于 Calquence 的疗法与化疗免疫疗法 (CIT) 方案进行了比较，该方案根据患者的年龄采用氟达拉滨、环磷酰胺和利妥昔单抗 (FCR) 或苯达莫司汀加利妥昔单抗。

Data from the study published in the

发表在《美国医学会杂志》上的研究数据

New England Journal of Medicine

新英格兰医学杂志

in February showed that 77% of patients treated with Calquence plus Venclexta and 83% of patients treated with Calquence, Venclexta and Gazyva were progression-free at three years, versus 67% of patients treated with standard CIT.

2月的数据显示，接受Calquence联合Venclexta治疗的患者中有77%在三年内无疾病进展，而接受Calquence、Venclexta和Gazyva联合治疗的患者中有83%在三年内无疾病进展，相比之下，接受标准CIT治疗的患者中这一比例为67%。

Calquence is a second-generation BTK inhibitor, with greater selectivity than the first-generation drug Johnson & Johnson's Imbruvica (ibrutinib) and fewer off-target effects. It has been approved for CLL since 2019 as a monotherapy or in combination with Gazyva, as well as for mantle cell lymphoma (MCL, and in first-line CLL was previously labeled for use until disease progression..

Calquence是一种第二代BTK抑制剂，相比第一代药物强生公司的Imbruvica（伊布替尼），其选择性更高，脱靶效应更少。自2019年以来，它已被批准用于CLL，作为单药治疗或与Gazyva联合使用，同时也适用于套细胞淋巴瘤（MCL），在一线CLL中此前被标示可用于疾病进展为止。

Latterly, it has been pressed in the marketplace by rival BTK inhibitor

最近，它在市场上受到 rival BTK 抑制剂的压力。

Brukinsa

布鲁金萨

(zanubrutinib) from BeOne (formerly BeiGene), which was cleared for first-line use in CLL in 2023 based on the results of the SEQUOIA trial and has grown rapidly to reach sales of $2.36 billion last year, around double its turnover in the prior year, across US and European markets.

百济神州（BeOne）的泽布替尼（zanubrutinib），该药在2023年基于SEQUOIA试验结果获批用于CLL的一线治疗，并迅速增长，去年在美国和欧洲市场实现23.6亿美元的销售额，几乎是前一年的两倍。

Calquence, meanwhile, has become AZ's third biggest-selling cancer medicine, with sales rising 25% last year to top $3.1 billion.

与此同时，Calquence 已成为阿斯利康第三大最畅销的抗癌药物，去年销售额增长了 25%，超过 31 亿美元。

Brukinsa's strong challenge stems in part from its position as the only BTK inhibitor to show superiority to Imbruvica in the second-line treatment setting, while Calquence showed equivalence.

布鲁金萨的强劲挑战部分源于它是唯一一种在二线治疗环境中显示出优于伊布替尼的BTK抑制剂，而卡尔森斯则显示出等效性。

'Calquence plus venetoclax is the first and only all-oral combination treatment option with a second-generation BTK inhibitor approved in the EU and provides patients and their physicians more flexibility in managing this incurable blood cancer,' commented Dave Fredrickson, head of AZ's blood cancer business unit..

“Calquence 加上 venetoclax 是首个也是唯一一个在欧盟获批的含第二代 BTK 抑制剂的全口服组合治疗方案，为患者及其医生提供了更大的灵活性来管理这种无法治愈的血癌，”阿斯利康血液肿瘤业务部负责人 Dave Fredrickson 表示。