FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection
正文 · 中文译文
FDA批准阿替利珠单抗与透明质酸酶-tqjs用于皮下注射 癌症批准 肿瘤（癌症）/血液系统恶性肿瘤批准通知 进行中 | 癌症加速批准 已证实临床获益 | 癌症加速批准 已撤回 | 癌症加速批准 其他 | 癌症加速批准 2024年9月12日，美国食品药品监督管理局（FDA）批准阿替利珠单抗与透明质酸酶-tqjs（Tecentriq Hybreza，Genentech， Inc.）皮下注射剂型，用于阿替利珠单抗静脉制剂（Tecentriq，Genentech， Inc.）的所有成人适应症，包括非小细胞肺癌（NSCLC）、小细胞肺癌（SCLC）、肝细胞癌（HCC）、黑色素瘤和腺泡状软组织肉瘤（ASPS）。具体适应症见处方信息。 Tecentriq Hybreza的完整处方信息将发布在Drugs@FDA上。 有效性与安全性 阿替利珠单抗与透明质酸酶-tqjs皮下注射剂在IMscin001（NCT03735121）中进行了评价，该研究是一项开放标签、多中心、国际、随机试验，纳入既往未接受过肿瘤免疫治疗且在含铂化疗后疾病进展的局部晚期或转移性NSCLC成人患者。共371例患者按（2：1）随机接受阿替利珠单抗与透明质酸酶-tqjs皮下注射或阿替利珠单抗静脉注射，直至疾病进展或出现不可接受的毒性。 主要结局指标为阿替利珠单抗暴露量，共同主要药代动力学（PK）终点为第1周期谷浓度（Ctrough）和0-21天曲线下面积（AUC0-21days）。其他描述性疗效结局指标为总缓解率（ORR）、无进展生存期（PFS）和总生存期（OS）。皮下阿替利珠单抗与静脉阿替利珠单抗第1周期Ctrough的几何均值比（GMR）（90% CI）为1.05（0.88，1.24），AUC0-21days为0.87（0.83，0.92），其GMR（90% CI）下限均高于预先设定的可比性阈值0.8。不同制剂之间未观察到ORR、PFS或OS的显著差异。皮下阿替利珠单抗与透明质酸酶-tqjs组的确诊ORR为9%（95% CI：5，13），静脉阿替利珠单抗组为8%（95% CI：4，14）。 任何级别最常见的不良反应（≥ 10%）为疲乏、肌肉骨骼疼痛、咳嗽、呼吸困难和食欲减退。 推荐剂量为每3周一次，在大腿皮下注射1支15 mL注射液（含1,875 mg阿替利珠单抗和30,000单位透明质酸酶），注射时间约7分钟。 加速审批程序 本审评使用了评估辅助工具（Assessment Aid），这是申请人自愿提交以促进FDA审评的材料。 医疗保健专业人员应将所有怀疑与使用任何药物和器械相关的严重不良事件报告至FDA的MedWatch报告系统，或致电1-800-FDA-1088。 对于研究性肿瘤产品的单患者IND申请协助，医疗保健专业人员可致电OCE的Project Facilitate，电话240-402-0004，或发送电子邮件至OncProjectFacilitate@fda.hhs.gov。 在X上关注肿瘤卓越中心：@FDAOncology。 内容更新日期： 09/12/2024 受监管产品 药物 肿瘤学
正文 · 英文原文
FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection Cancer Approvals Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). See the prescribing information for the specific indications. Full prescribing information for Tecentriq Hybreza will be posted on Drugs@FDA. Efficacy and Safety The subcutaneous injection of atezolizumab and hyaluronidase-tqjs was evaluated in IMscin001 (NCT03735121), an open-label, multi-center, international, randomized trial in adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. A total of 371 patients were randomized (2:1) to receive subcutaneous atezolizumab and hyaluronidase-tqjs or intravenous atezolizumab until disease progression or unacceptable toxicity. The primary outcome measure was atezolizumab exposure, with coprimary pharmacokinetic (PK) endpoints of Cycle 1 Ctrough and AUC0-21days. Additional descriptive efficacy outcome measures were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). The geometric mean ratio (GMR) (90% CI) of subcutaneous atezolizumab and intravenous atezolizumab for Cycle 1 Ctrough was 1.05 (0.88, 1.24) and AUC0-21days was 0.87 (0.83, 0.92), which met the lower limit of the GMR (90% CI) above the pre-specified threshold of 0.8 for comparability. No notable differences in ORR, PFS or OS were observed between the different formulations. The confirmed ORR was 9% (95% CI: 5, 13) in the subcutaneous atezolizumab and hyaluronidase-tqjs arm and 8% (95% CI: 4, 14) in the intravenous atezolizumab arm. The most common adverse reactions of any grade (≥ 10%) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. The recommended dosage is one 15 mL injection (containing 1,875 mg of atezolizumab and 30,000 units of hyaluronidase) administered subcutaneously in the thigh over approximately 7 minutes every 3 weeks. Expedited Programs This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. Follow the Oncology Center of Excellence on X: @FDAOncology. Content current as of: 09/12/2024 Regulated Product(s) Drugs Oncology
摘要 待译
On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.).