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Genentech, a member of the Roche Group (RHHBY), said Thursday that the U.S. Food and Drug Administration has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the United States. It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin and soft tissue cancer.Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab).'By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,' said Levi Garraway, chief medical officer and head of Global Product Development..
罗氏集团(RHHBY)成员基因泰克(Genentech)周四表示,美国食品和药物管理局已批准Tecentriq Hybreza(atezolizumab和透明质酸酶tqjs),这是美国第一个也是唯一一个用于皮下注射(SC)的PD-(L)1抑制剂。它将适用于美国成年人批准的Tecentriq的所有IV适应症,包括某些类型的肺癌,肝癌,皮肤癌和软组织癌。Tecentriq Hybreza可以在大约7分钟内皮下注射,而标准IV输注Tecentriq(atezolizumab)需要30-60分钟首席医疗官兼全球产品开发负责人莱维·加拉韦(Levi Garraway)说,通过使皮下注射用于癌症免疫疗法,Tecentriq Hybreza现在为多种癌症类型的患者及其医生提供了更大的灵活性和治疗管理选择。。
The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in over 50 countries (outside the U.S. marketed as Tecentriq SC). Regulatory reviews in other countries and regions are ongoing.For More Such Health News, visit rttnews.com.
Tecentriq的皮下制剂于2023年8月在英国首次获得全球批准,目前已在50多个国家获得批准(美国以外的市场称为Tecentriq SC)。其他国家和地区正在进行监管审查。欲了解更多此类健康新闻,请访问rttnews.com。
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