Health Canada approves CALQUENCE for adult patients with previously-treated mantle cell lymphoma

加拿大卫生部批准Calquent作为口服性治疗细胞淋巴瘤药物

2019-10-09 14:00:31 BioSpace

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MISSISSAUGA, ON, Oct. 8, 2019 /CNW/ - AstraZeneca Canada Inc.  today announced the Health Canada approval of Calquence® as an oral therapy for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. A Notice of Compliance for Calquence was granted based on positive data from the ACE-LY-004 trial which demonstrated an 81% overall response rate for patients with relapsed or refractory MCL.1 MCL is a rare B-cell form of non-Hodgkin's lymphoma most common in men over the age of 50. Usually diagnosed in the late stages, MCL often spreads to other organs including the bone marrow, spleen and liver. Many MCL patients initially respond to treatment, but a high rate of relapse may lead to poor prognosis.2 "The results of the ACE-LY-004 trial are very promising for MCL patients," said Dr. John Kuruvilla, Hematologist and Associate Professor of Medicine, University of Toronto. "Calquence is highly selective in targeting BTK and its minimal interactions with other targets means it can offer the potential for reduced toxicity and improved efficacy." Calquence is a selective inhibitor of Bruton's tyrosine kinase (BTK). Calquence binds irreversibly to BTK to inhibit its activity, and has demonstrated this with minimal interference to other immune cells or kinases in pre-clinical studies.1,3,4,5  About Mantle Cell Lymphoma (MCL) MCL is an aggressive B-cell non-Hodgkin lymphoma (NHL) with poor prognosis.2 MCL accounts for approximately 5% to 10% of new NHL cases in Canada each year, with an annual incidence of 0.5 per 100,000 people in Western countries.2,6 The median age at diagnosis is 68 years, and occurs more often in men than women.6 While MCL patients initially respond to treatment, there is a high frequency of recurrence.6 About Calquence Calquence (acalabrutinib; previously known as ACP-196) is a selective inhibitor of Bruton's tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity, and has demonstrated this with minimal interactions with other immune cells in pre-clinical studies.1,4,5 In B cells, BTK signaling results in activation of pathways necessary for B cell proliferation, trafficking, chemotaxis and adhesion.1 The recommended dose of Calquence is one 100mg capsule taken orally twice daily (approximately 12 hours apart), until disease progression or unacceptable toxicity.1 Calquence may be taken with or without food.1 About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca. References _______________________ 1 AstraZeneca Canada Inc., Calquence® (acalabrutinib), Product Monograph. August 2019. 2 Lymphoma Canada. Non-Hodgkin Lymphoma. NHL Subtypes. Accessed August 2019. Available at: https://www.lymphoma.ca/lymphoma/non-hodgkin-lymphoma/nhl-subtypes#3 3 Covey T, Barf T, Gulrajani M, Krantz F, van Lith B, Bibikova E, et al. Abstract 2596: ACP-196: a novel covalent Bruton's tyrosine kinase (Btk) inhibitor with improved selectivity and in vivo target coverage in chronic lymphocytic leukemia (CLL) patients. Cancer Res. 2015;75(15 Supplement):2596. 4 Byrd JC, Harrington B, O'Brien S, Jones JA, Schuh A, Devereux S, et al. Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. N Engl J Med. 2016;374(4):323–32. 5 Harrington BK, Gulrajani M, Covey T, Kaptein A, Van Lith B, Izumi R, et al. ACP-196 is a second generation inhibitor of Bruton tyrosine kinase (BTK) with enhanced target specificity. Blood. 2015;126(23):2908. 6 Cheah CY, Seymour JF, Wang M. Mantle Cell Lymphoma. J Clin Oncol. 2016; 34(11):1256-1269. Accessed August 2019. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26755518 SOURCE AstraZeneca Canada Inc.
阿斯利康(AstraZeneca) Canada Inc .今天宣布加拿大卫生部批准 Calquent ®作为口服治疗口服性细胞淋巴瘤患者的治疗方法,这些患者至少接受了一次先前的治疗。根据 ACE-LY-004试验的阳性数据,批准了一份符合钙调的通知,该试验显示复发或难治性 MCL 患者的总有效率为81%。1 MCL 是一种罕见的 B 细胞形式的非霍奇金淋巴瘤最常见的男性超过50岁。通常在晚期诊断, MCL 通常会传播到其他器官,包括骨髓,脾脏和肝脏。许多 MCL 患者最初对治疗有反应,但复发率高可能导致预后不良。2 “ ACE-LY-004试验的结果对 MCL 患者非常有希望,”多伦多大学血液学家和医学副教授 John Kuruvela 博士说。热淬火剂对 BTK 的靶向性很强,与其它靶的相互作用很小,这意味着它可以降低毒性,提高疗效。 钙解质是布鲁顿酪氨酸激酶( BTK )的选择性抑制剂。钙质与 BTK 不可逆地结合以抑制其活性,并在临床前研究中以对其他免疫细胞或激酶的最小干扰证明了这一点。1,3,4,5 关于单细胞淋巴瘤( MCL ) MCL 是一种侵袭性的 B 细胞非霍奇金淋巴瘤( NHL ),预后差。2 MCL 在加拿大每年约占新 NHL 病例的5%至10%,在西方国家,每年每10万人发生0.5例。诊断中位年龄为68岁,男性多于女性。6虽然 MCL 患者最初对治疗作出反应,但复发的频率很高。6、6 关于温度问题 钙解质(阿卡拉鲁替尼;以前称为 ACP-196)是布鲁顿酪氨酸激酶( BTK )的选择性抑制剂。钙质与 BTK 具有共价结合,从而抑制其活性,并在临床前研究中与其他免疫细胞的相互作用很小。1,4,5在 B 细胞中, BTK 信号导致激活 B 细胞增殖、贩运、趋化和粘附所必需的通路。1推荐剂量为每日口服两次100毫克胶囊(间隔约12小时),直到疾病进展或不可接受的毒性。1无论有没有食物,都可以饮用加钙。1 关于阿斯利康(AstraZeneca) 阿斯利康(AstraZeneca)是一家全球创新驱动的生物制药企业,主要致力于发现、开发和商业化改变生活的初级和特殊护理药品。我们的主要重点是三个重要领域的医疗保健:心血管和代谢疾病;肿瘤;呼吸,炎症和自身免疫。阿斯利康(AstraZeneca)在100多个国家开展业务,其创新药物被全球数百万患者使用。在加拿大,我们在全国雇用超过675名员工,我们的总部位于加拿大安大略省的 Mississauga 。欲了解更多信息,请访问公司网站 www.astazineca.ca 。 参考文献 _____________ 1 阿斯利康(AstraZeneca) Canada Inc ., Calquent ®(阿卡拉鲁替尼),产品专著。2019年8月。 2 加拿大淋巴瘤.非霍奇金淋巴瘤.NHL 子类型.进入2019年8月。http://www.淋巴瘤.ca/淋巴瘤/非霍奇金淋巴瘤/nhl-subtypes #3 3. Covey T , Barf T , Gurrjani M , Krantz F , van Liti B , Bibibikova E , et al .文摘2596: ACP-196:一种新型共价布鲁顿酪氨酸激酶( Btk )抑制剂,提高了慢性淋巴细胞白血病( CLL )患者的选择性和体内靶向性。癌症研究。2015年;75(15补充条款): 4 Byrd JC , Harrington B , O'Brien S , Jones JA , Schuh A , Devereux S 等.阿卡布曲替尼( ACP-196)治疗复发慢性淋巴细胞白血病.英国医学博士.2016年;374(4):323-32。 5、5 Harrington BK , Gullajani M , Covey T , Kaptein A , Van Liti B , Izumi R 等。ACP-196是 Bruton 酪氨酸激酶( BTK )的第二代抑制剂,具有增强的靶向性。血液。2015年;126(23):2908。 6、6 Cheah CY , Seymour JF , Wang M . Manll 细胞淋巴瘤。J Clin Oncol 。2016年;34(11):进入2019年8月。http://www.ncbi.nlm.nih.gov/pubmed/26755518 加拿大阿斯利康(AstraZeneca)公司.

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