FDA批准阿替利珠单抗联合化疗用于III期错配修复缺陷型结肠癌
正文 · 中文译文
FDA批准阿替利珠单抗联合化疗用于III期错配修复缺陷型结肠癌 信息资源 | 已批准药物 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 已验证临床获益 | 癌症加速批准 已撤回 | 癌症加速批准 其他 | 癌症加速批准 2026年10月8日，美国食品药品监督管理局（FDA）批准阿替利珠单抗（Tecentriq，基因泰克公司）联合氟嘧啶和奥沙利铂用于2岁及以上成人和儿童III期错配修复缺陷（dMMR）结肠癌患者的辅助治疗。FDA还批准了阿替利珠单抗和透明质酸酶-tqjs（Tecentriq Hybreza，基因泰克公司）联合氟嘧啶和奥沙利铂用于12岁及以上、体重40 kg或以上的成人和儿童III期dMMR结肠癌患者的辅助治疗。 Tecentriq和Tecentriq Hybreza的完整处方信息将发布在Drugs@FDA上。 疗效与安全性 在ATOMIC/ML39057（NCT02912559）中评估了疗效，该研究是一项多中心、随机、开放标签、活性对照试验，纳入711例成人及1例儿童III期dMMR结肠癌患者，患者在原发肿瘤完全切除后无残留淋巴结受累或转移性疾病的证据。患者按1：1随机接受阿替利珠单抗联合mFOLFOX6（奥沙利铂、亚叶酸钙和氟尿嘧啶）治疗12个周期，随后阿替利珠单抗单药治疗6个月，或仅接受mFOLFOX6治疗12个周期。 主要疗效结局指标为研究者评估的无病生存期（DFS）。DFS比较的风险比为0.50（95% CI：0.35，0.73；p值0.0001），两臂的中位DFS均未达到（NR）。 处方信息包括针对免疫介导的不良反应、输注相关反应、异基因造血干细胞移植并发症以及胚胎-胎儿毒性的警告和注意事项。 推荐剂量 成人患者的推荐阿替利珠单抗剂量为每两周840 mg、每三周1200 mg或每四周1680 mg，静脉给药，与化疗联合使用6个月，随后阿替利珠单抗单药治疗6个月，或直至疾病复发或出现不可接受的毒性。儿童患者的推荐剂量为每两周10 mg/kg（最高840 mg）或每三周15 mg/kg（最高1200 mg），与化疗联合使用6个月，随后阿替利珠单抗单药治疗6个月，或直至疾病复发或出现不可接受的毒性，以先发生者为准。 阿替利珠单抗和透明质酸酶-tqjs在成人及体重40 kg或以上的12岁及以上儿童患者中的推荐剂量为每三周一次15 mL注射（含1875 mg阿替利珠单抗和30,000单位透明质酸酶），皮下给药，与化疗联合使用6个月，随后阿替利珠单抗和透明质酸酶-tqjs作为单药治疗6个月，或直至疾病复发或出现不可接受的毒性，以先发生者为准。12岁以下儿童患者及体重低于40 kg的12岁及以上患者的推荐剂量尚未确定。 本综述在Project Orbis框架下开展，该项目是美国食品药品监督管理局（FDA）肿瘤卓越中心的一项倡议。Project Orbis为国际合作伙伴之间肿瘤药物的同步提交和审评提供了框架。本次审评中，FDA与澳大利亚治疗用品管理局（TGA）、加拿大卫生部（HC）、以色列卫生部（ImoH）以及瑞士瑞士治疗产品管理局（Swissmedic）合作。其他监管机构的申请审评仍在进行中。 本审评使用了Assessment Aid，这是申请人自愿提交以促进FDA评估的文件。 这些申请获得了优先审评。FDA加速程序的描述见《行业指南：严重疾病药物和生物制品的加速程序》。 医疗保健专业人员应将所有怀疑与任何药物和器械使用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。 如需关于研究性肿瘤产品单患者IND的协助，医疗保健专业人员可联系OCE的Project Facilitate，电话240-402-0004，或发送电子邮件至OncProjectFacilitate@fda.hhs.gov。 内容截至日期： 10/08/2026 受监管产品 药物
正文 · 英文原文
FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer Resources for Information | Approved Drugs 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Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals On October 8, 2026, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. The FDA also approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients 12 years of age and older who weigh 40 kg or greater with Stage III dMMR colon cancer. Full prescribing information for Tecentriq and Tecentriq Hybreza will be posted on Drugs@FDA . Efficacy and Safety Efficacy was evaluated in ATOMIC/ML39057 (NCT02912559), a multicenter, randomized, open-label, active-controlled trial in 711 adults and one pediatric patient with Stage III dMMR colon cancer after a complete resection of the primary tumor with no evidence of residual lymph node involvement or metastatic disease. Patients were randomized (1:1) to receive either atezolizumab in combination with mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil) for 12 cycles followed by atezolizumab monotherapy for 6 months, or mFOLFOX6 alone for 12 cycles. The major efficacy outcome measure was disease-free survival (DFS) as assessed by the investigator. The hazard ratio for the DFS comparison was 0.50 (95% CI: 0.35, 0.73; p-value 0.0001), and the median DFS was not reached (NR) in either arm. The prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem-cell transplantation, and embryo-fetal toxicity. Recommended Dosage The recommended atezolizumab dose for adult patients is 840 mg every two weeks, 1200 mg every three weeks, or 1680 mg every four weeks administered intravenously in combination with chemotherapy for six months, followed by atezolizumab as a single agent for six months or until disease recurrence or unacceptable toxicity. The recommended dose for pediatric patients is 10 mg/kg (up to a maximum of 840 mg) every two weeks or 15 mg/kg (up to a maximum of 1200 mg) every three weeks in combination with chemotherapy for six months, followed by atezolizumab as a single agent for six months or until disease recurrence or unacceptable toxicity, whichever occurs first. The recommended dosage of atezolizumab and hyaluronidase-tqjs in adults and pediatric patients 12 years of age and older who weigh 40 kg or greater is one 15 mL injection every three weeks (containing 1875 mg of atezolizumab and 30,000 units of hyaluronidase) administered subcutaneously in combination with chemotherapy for six months, followed by atezolizumab and hyaluronidase-tqjs as monotherapy for six months or until disease recurrence or unacceptable toxicity, whichever occurs first. The recommended dosage for pediatric patients under 12 years of age and patients 12 years of age and older who weigh less than 40 kg has not been established. This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada (HC), Israel’s Ministry of Health (ImoH), and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. These applications were granted priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. 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. Content current as of: 10/08/2026 Regulated Product(s) Drugs