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Roche Receives European Commission Approval of Tecentriq SC With Halozyme's ENHANZE Representing The EU's First Subcutaneous PD-(L)1 Cancer Immunotherapy For Multiple Cancer Types

Roche Receives European Commission Approval of Tecentriq SC With Halozyme's ENHANZE Representing The EU's First Subcutaneous PD-(L)1 Cancer Immunotherapy For Multiple Cancer Types

罗氏获得欧盟委员会对Tecentriq SC的批准,Halozyme的ENHANZE是欧盟首款针对多种癌症类型的皮下PD-(L)1癌症免疫疗法
Benzinga ·  01/16 01:57

Reduces treatment time by approximately 80% compared to standard intravenous (IV) infusion

与标准静脉 (IV) 输注相比,治疗时间缩短了大约 80%

Subcutaneous (SC) injection offers the potential for a faster, more convenient alternative to IV infusion and is preferred by patients and healthcare practitioners1 - 6.

皮下(SC)注射有可能为静脉输注提供更快、更便捷的替代方案,是患者和医疗保健从业人员的首选1-6。

"As the first subcutaneous PD-(L)1 cancer immunotherapy in Europe, Tecentriq SC can provide a new treatment option that can enhance the treatment experience for patients and caregivers while freeing up resources in constrained healthcare systems," said Dr. Helen Torley, president and chief executive officer of Halozyme.

Halozyme总裁兼首席执行官海伦·托利博士表示:“作为欧洲第一种皮下PD-(L)1癌症免疫疗法,Tecentriq SC可以提供一种新的治疗选择,可以增强患者和护理人员的治疗体验,同时为受限的医疗系统腾出资源。”

The EC approval follows pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. The study found 90% of healthcare professionals agreed that the SC formulation is easy to administer and 75% said it could save time for healthcare teams compared with the IV formulation6.

欧盟委员会的批准遵循了IB/III期imsCin001研究的关键数据,该研究显示,皮下给药时,血液中的Tecentriq水平相当,安全性和有效性与静脉注射配方一致。该研究发现,90%的医疗保健专业人员认为SC配方易于服用,75%的医疗保健专业人员表示,与静脉注射配方相比,它可以为医疗团队节省时间6

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