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美国食品药品监督管理局批准癌症药物的首个注射版本

FDA Approves First Injectable Version of Cancer Drug

WebMD 等信源发布 2024-09-18 22:41

可切换为仅中文


Sept. 18, 2024 – The FDA has approved an injectable form of the cancer drug atezolizumab in combination with the enzyme hyaluronidase for use in patients with certain types of cancers of the lung, liver, skin, and soft tissues. It offers an easier-to-use and less time-consuming alternative to the currently available form of the drug.The combination works by helping the body's immune system identify and attack cancer cells.

2024年9月18日,FDA批准了一种可注射形式的抗癌药物atezolizumab联合透明质酸酶用于某些类型的肺癌、肝癌、皮肤癌和软组织癌患者。与目前可用的药物形式相比,它提供了一种更容易使用且耗时更少的替代品。这种组合的作用是帮助身体的免疫系统识别和攻击癌细胞。

It targets PD-L1, a protein that normally helps cancer cells hide from the immune system. Hyaluronidase makes it easier for atezolizumab to be absorbed when injected under the skin. The new drug will be marketed under the brand name Tecentriq Hybreza.In approving the new treatment method, the FDA cited clinical studies that showed comparable levels of atezolizumab in the blood when injected beneath the skin and a safety and efficacy profile comparable with that of the standard intravenous treatment.

它靶向PD-L1,一种通常帮助癌细胞逃避免疫系统的蛋白质。透明质酸酶使阿唑珠单抗在皮肤下注射时更容易被吸收。这种新药将以Tecentriq Hybreza品牌销售。在批准新的治疗方法时,FDA引用了临床研究,这些研究表明,当注射到皮肤下时,血液中的atezolizumab水平相当,安全性和有效性与标准静脉注射治疗相当。

The FDA said the injectable form can be administered in about 7 minutes, every 3 weeks. That compares to about 30 minutes to 60 minutes treatment time for the current infusion method. The common side effects included fatigue, muscle and bone pain, cough, shortness of breath, and decreased appetite. Genentech, the drug’s manufacturer, said in a press release that a clinical trial found that 71% of patients preferred the improved ease of use of Tecentriq Hybreza to intravenous atezolizumab because it required less time spent in a clinic, provided greater comfort, and reduced emotional distress.

美国食品和药物管理局(FDA)表示,这种注射剂每3周服用一次,大约需要7分钟。相比之下,目前的输液方法大约需要30分钟到60分钟的治疗时间。常见的副作用包括疲劳,肌肉和骨骼疼痛,咳嗽,呼吸急促和食欲下降。。

The approval marks Tecentriq Hybreza as the first anti-PD-(L)-1 cancer immunotherapy drug available as a subcutaneous injection.The injectable form of the cancer immunotherapy drug 'offers patients with multiple cancer types and their physicians greater flexibility an.

该批准标志着Tecentriq Hybreza是第一种可作为皮下注射使用的抗PD-(L)-1癌症免疫治疗药物。癌症免疫治疗药物的可注射形式“为多种癌症类型的患者及其医生提供了更大的灵活性和灵活性。