MISSISSAUGA, ON, April 23, 2024 /CNW/ - F. Hoffmann-La Roche Ltd. (Roche Canada) is pleased to announce that on March 13, 2024, Health Canada issued marketing authorization for Tecentriq® SC (atezolizumab, solution for subcutaneous injection), the first cancer immunotherapy for subcutaneous (under the skin injection) administration in Canada, for specific indications in lung cancer, hepatocellular carcinoma (HCC or liver cancer), and breast cancer.1.

MISSISSAUGA，ON，2024年4月23日/CNW/-F.Hoffmann-La Roche Ltd.（加拿大罗氏公司）高兴地宣布，2024年3月13日，加拿大卫生部发布了Tecentriq®SC（atezolizumab，皮下注射溶液）的上市许可，这是加拿大第一个用于皮下（皮肤注射）给药的癌症免疫疗法，用于肺癌，肝细胞癌（HCC或肝癌）和乳腺癌的特定适应症。

Until now, Tecentriq has been given directly into patients' veins by IV infusion, which takes approximately 30-60 minutes.2 The new subcutaneous injection aims to provide an alternative active administration time of approximately seven minutes, with injections taking between three and fourteen minutes.1 In addition to offering an alternative administration time, Tecentriq SC has the potential to be administered outside of the hospital, in a community care setting or at a patient's home, by a qualified healthcare professional. .

到目前为止，Tecentriq已经通过静脉输注直接进入患者的静脉，大约需要30-60分钟。2新的皮下注射旨在提供大约7分钟的替代主动给药时间，注射时间在3到14分钟之间。1除了提供替代给药时间外，Tecentriq SC还有可能在医院外，社区护理机构或患者家中由合格的医疗保健专业人员进行给药。。

'While immunotherapy has greatly changed outcomes for many cancer patients, the burden of treatment remains significant. Patients must navigate family, social and financial responsibilities, on top of frequent travel to receive intravenous immune therapy,' says Dr. Sara Moore, Medical Oncologist at The Ottawa Hospital.

“虽然免疫疗法极大地改变了许多癌症患者的预后，但治疗负担仍然很重。渥太华医院肿瘤内科医师萨拉·摩尔（SaraMoore）博士说，除了频繁旅行接受静脉免疫治疗外，患者还必须承担家庭、社会和经济责任。

'This burden can disproportionately affect patients in more rural or remote areas, who can't easily access infusion centers. The availability of subcutaneous treatment options is a great step towards bringing cancer care closer to home.'.

“这一负担可能会不成比例地影响到更多农村或偏远地区的患者，他们无法轻松进入输液中心。皮下治疗方案的可用性是将癌症护理带到离家更近的一大步。”。

By providing this additional option, we aim to demonstrate our commitment to investing in and delivering innovative solutions that bring additional value to patients, and alleviate existing burdens in our constrained healthcare systems.

通过提供这种额外的选择，我们旨在展示我们对投资和提供创新解决方案的承诺，这些解决方案为患者带来额外的价值，并减轻我们有限的医疗保健系统的现有负担。

'The adoption of SC immunotherapy in lung cancer provides tangible benefits for patients and health care providers,' says Michelle Forman, RN, CON(c), Oncology Nurse, at Burnaby Hospital Cancer Centre. 'For patients, it offers practical benefits like reduced time spent in the clinic, less invasive administration, and greater flexibility with scheduling.

“SC免疫疗法在肺癌中的应用为患者和医疗保健提供者提供了切实的好处，”伯纳比医院癌症中心肿瘤科护士MichelleForman说对于患者来说，它提供了实际的好处，例如减少了在诊所的时间，减少了侵入性的管理，以及更大的调度灵活性。

It also enables treatment closer to home, reducing travel stress.'.

它还可以在离家更近的地方进行治疗，减轻旅行压力。”。

Forman adds that, 'For healthcare providers, the fixed dosage of SC immunotherapy formulation can help to optimize resource utilization, simplify ordering, and enhance patient safety by reducing the likelihood of dosage calculation errors. Additionally, the time saved administering immunotherapy subcutaneously can improve workflow efficiency.'.

Forman补充说，“对于医疗保健提供者来说，固定剂量的SC免疫治疗制剂可以通过减少剂量计算错误的可能性来帮助优化资源利用率，简化订购并提高患者安全性。此外，皮下注射免疫疗法节省的时间可以提高工作效率。”。

'The disease burden is high for those living with lung cancer, and treatment innovation is critical to ensuring hope for patients,' said Shem Singh, Executive Director of Lung Cancer Canada. 'We welcome the approval of Tecentriq SC as it will allow more Canadians living with lung cancer to have the flexibility of an additional treatment option when it comes to managing their disease and improving quality of life.'.

“肺癌患者的疾病负担很重，治疗创新对于确保患者的希望至关重要，”加拿大肺癌执行董事Shem Singh说我们欢迎Tecentriq SC的批准，因为它将使更多患有肺癌的加拿大人在管理疾病和改善生活质量方面拥有额外治疗选择的灵活性。”。

Roche Canada now looks forward to working together with the pan-Canadian Pharmaceutical Alliance (pCPA), as well as the provincial and territorial governments, to achieve sustainable, equitable access to Tecentriq SC. We are hopeful that the unique value of Tecentriq SC for patients, healthcare providers and healthcare systems will be recognized and made available to all Canadian patients who need it..

罗氏加拿大公司现在期待着与泛加拿大制药联盟（pCPA）以及省和地区政府合作，以实现可持续、公平地使用Tecentriq SC。我们希望Tecentriq SC对患者、医疗保健提供者和医疗保健系统的独特价值将得到认可，并提供给所有需要它的加拿大患者。。

The marketing authorization of Tecentriq SC is based on results from the pivotal data from Part 2 of the Phase IB/III IMscin001 study, which showed that treatment with Tecentriq SC produced non-inferior levels of atezolizumab in the blood versus intravenous administration of Tecentriq.1 The marketing authorization applies to all authorized indications of Tecentriq (intravenous formulation), with specific indications in lung cancer, hepatocellular carcinoma (HCC or liver cancer), and breast cancer, providing this additional option to patients in all eight indications, in three cancer areas..

Tecentriq SC的上市授权基于IB/III期IMscin001研究第2部分的关键数据的结果，该研究表明，与静脉注射Tecentriq相比，使用Tecentriq SC的治疗在血液中产生的atezolizumab水平不低于静脉注射Tecentriq。1上市授权适用于Tecentriq（静脉制剂）的所有授权适应症，具有肺癌，肝细胞癌（HCC或肝癌）和乳腺癌的特定适应症，为三个癌症领域的所有八种适应症的患者提供了这一额外选择。。

About Tecentriq SC (subcutaneous)1

关于Tecentriq SC（皮下）1

Atezolizumab in Tecentriq SC is the same monoclonal antibody as in Tecentriq (intravenous formulation). It has been designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.

Tecentriq SC中的Atezolizumab与Tecentriq（静脉制剂）中的单克隆抗体相同。它被设计为与称为程序性死亡配体-1（PD-L1）的蛋白质结合，该蛋白质在肿瘤细胞和肿瘤浸润性免疫细胞上表达，阻断其与PD-1和B7.1受体的相互作用。

This protein makes the immune system in your body not work as well. By attaching to the PD-L1 protein, Tecentriq may help the immune system fight the cancer..

这种蛋白质使你体内的免疫系统不能正常工作。通过附着PD-L1蛋白，Tecentriq可能有助于免疫系统对抗癌症。。

Tecentriq is a type of cancer immunotherapy treatment. Immunotherapy treatments work by helping to strengthen or restore the immune system's ability to fight the cancerous cells.3

Tecentriq是一种癌症免疫疗法。免疫疗法的作用是帮助增强或恢复免疫系统抵抗癌细胞的能力。3

The marketing authorization applies to all authorized indications of Tecentriq (intravenous formulation), with specific indications in lung cancer, hepatocellular carcinoma (HCC or liver cancer), and breast cancer.

上市授权适用于Tecentriq（静脉制剂）的所有授权适应症，具有肺癌，肝细胞癌（HCC或肝癌）和乳腺癌的特定适应症。

About the Health Canada Authorization1

关于加拿大卫生部授权1

The authorization of Tecentriq SC by Health Canada is based on Part 2 of the IMscin001 study. IMscin001 is a Phase IB/III, global, multicentre, randomized study evaluating the pharmacokinetics, safety and efficacy of atezolizumab subcutaneous compared with atezolizumab intravenous in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed.

加拿大卫生部对Tecentriq SC的授权基于IMscin001研究的第2部分。IMscin001是一项IB/III期全球多中心随机研究，评估皮下注射atezolizumab与静脉注射atezolizumab相比在局部晚期或转移性非小细胞肺癌（NSCLC）患者中的药代动力学，安全性和有效性，这些患者尚未接受过癌症免疫治疗（CIT），之前的铂类治疗失败。

The study enrolled 371 patients..

该研究招募了371名患者。。

The study met its primary endpoints, demonstrating that treatment with Tecentriq SC produced non-inferior levels of atezolizumab in the blood versus intravenous administration of Tecentriq on the basis of established pharmacokinetic measurements; observed serum Ctrough and model-predicted area under the curve..

该研究达到了其主要终点，表明根据已建立的药代动力学测量，与静脉注射Tecentriq相比，用Tecentriq SC治疗在血液中产生了非劣效水平的atezolizumab；观察到的血清Ctrough和模型预测的曲线下面积。。

About Roche Canada

罗氏加拿大简介

At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies.

在加拿大罗氏公司，患者和科学是我们所做一切的核心。我们对科学的热情和对患者不可能的不懈追求，使我们成为世界领先的制药、体外诊断和糖尿病护理管理公司之一。

With our combined strength in diagnostics and pharmaceuticals, we're driving personalized healthcare (PHC) forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone.

凭借我们在诊断和制药方面的综合实力，我们正在推动个性化医疗（PHC）向前发展，同时确保我们为患者提供有意义的利益和可持续的医疗保健系统。因为我们致力于让每个人都能获得优质的医疗保健。

And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries.

我们正在增加新领域的专业知识，如人工智能、现实世界的数据收集和分析以及与许多不同部门和行业的合作。

Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec..

有勇气重塑自己，质疑现状，这是患者和医疗保健系统对罗氏的期望，我们今天的承诺与1931年我们加拿大之旅的第一天一样坚定。如今，罗氏加拿大公司通过其位于安大略省米西索加的制药部门以及位于魁北克省拉瓦尔的诊断和糖尿病护理部门，在全国拥有1800多名员工。