FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer
正文 · 中文译文
FDA批准阿来替尼作为ALK阳性非小细胞肺癌的辅助治疗 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4月18日，美国食品药品监督管理局（FDA）批准阿来替尼（Alecensa，基因泰克公司）用于经FDA批准的检测方法检出间变性淋巴瘤激酶（ALK）阳性的非小细胞肺癌（NSCLC）患者肿瘤切除术后的辅助治疗。 Alecensa的完整处方信息将在此处发布。 疗效与安全性 疗效在一项全球、随机、开放标签试验（ALINA，NCT03456076）中得到了证实，该试验纳入的是接受过完整肿瘤切除术的ALK阳性NSCLC患者。合格患者须为可切除的IB期（肿瘤≥ 4 cm）至IIIA期NSCLC（依据AJCC第7版），且ALK重排经当地执行的FDA批准的ALK检测或中心实验室执行的VENTANA ALK（D5F3）CDx检测确认。共有257例患者在肿瘤切除术后被随机分配（1：1）接受阿来替尼600 mg口服每日两次或含铂化疗。 主要疗效结局指标为研究者评估的II-IIIA期NSCLC患者亚组的无病生存期（DFS）以及总体研究人群（IB-IIIA期）的DFS。在II-IIIA期NSCLC患者中，阿来替尼组的中位DFS未达到（95% CI：不可估计[NE]，NE），化疗组为44.4个月（95% CI：27.8，NE）（HR 0.24 [95% CI：0.13，0.45]；p<0.0001）。总体研究人群中观察到相似结果，阿来替尼组中位DFS未达到（95% CI：NE，NE），化疗组为41.3个月（95% CI：28.5，NE）（HR 0.24 [95% CI：0.13，0.43]；p<0.0001）。 服用阿来替尼的患者中最常见（≥ 20%）的不良反应为肝毒性、便秘、肌痛、COVID-19、疲劳、皮疹和咳嗽。 阿来替尼的推荐剂量为600 mg口服，每日两次，随餐服用，持续2年或直至疾病复发或出现不可接受的毒性。 本审评在Project Orbis框架下进行，该项目是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、加拿大卫生部、以色列卫生部、瑞士瑞士治疗产品管理局以及英国药品和保健产品监管局进行了合作。涉及Project Orbis的其他监管机构的申请审评正在进行中。 本综述采用了实时肿瘤学审评（RTOR）试点项目，该项目在完整临床应用申报提交之前简化了数据提交过程，以及评估辅助工具（Assessment Aid），这是申请人自愿提交以促进FDA评估的材料。FDA比FDA目标日期提前一个月批准了该申请。 加快审评项目 本申请获得了优先审评和孤儿药认定。FDA加快审评项目在《行业指南：严重疾病药物和生物制品的加快审评项目》中有描述。 医疗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。 如需有关研究性肿瘤产品单患者IND的协助，医疗专业人员可联系OCE的Project Facilitate，电话240-402-0004，或发送电子邮件至OncProjectFacilitate@fda.hhs.gov。 在X（原Twitter）上关注肿瘤学卓越中心 @FDAOncology。 内容截至日期： 04/18/2024 受监管产品 药物 肿瘤学
正文 · 英文原文
FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer 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Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Full prescribing information for Alecensa will be posted here. Efficacy and Safety Efficacy was demonstrated in a global, randomized, open-label trial (ALINA, NCT03456076) in patients with ALK-positive NSCLC who had complete tumor resection. Eligible patients were required to have resectable Stage IB (tumors ≥ 4 cm) to IIIA NSCLC (by AJCC 7th edition) with ALK rearrangements identified by a locally performed FDA-approved ALK test or by a centrally performed VENTANA ALK (D5F3) CDx assay. A total of 257 patients were randomized (1:1) to receive alectinib 600 mg orally twice daily or platinum-based chemotherapy following tumor resection. The major efficacy outcome measures were disease-free survival (DFS) in the subgroup of patients with stage II-IIIA NSCLC and DFS in the overall study population (stage IB-IIIA), as assessed by investigator. In patients with stage II-IIIA NSCLC, median DFS was not reached (95% CI: not estimable [NE], NE) in the alectinib arm and 44.4 months (95% CI: 27.8, NE) in the chemotherapy arm (HR 0.24 [95% CI: 0.13, 0.45]; p<0.0001). Similar results were seen in the overall study population with median DFS not reached (95% CI: NE, NE) in the alectinib arm and 41.3 months (95% CI: 28.5, NE) in the chemotherapy arm (HR 0.24 [95% CI: 0.13, 0.43]; p<0.0001). The most common (≥ 20%) adverse reactions in patients taking alectinib were hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash, and cough. The recommended alectinib dose is 600 mg orally twice daily with food for 2 years or until disease recurrence or unacceptable toxicity. 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, Health Canada, Israel’s Ministry of Health, Switzerland’s Swissmedic, and United Kingdom’s Medicines and Healthcare products Regulatory Agency. The application reviews are ongoing at other regulatory agencies involved with Project Orbis. This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application one month ahead of the FDA goal date. Expedited Programs This application was granted priority review and orphan drug designation. FDA expedited programs are described 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. Follow the Oncology Center of Excellence on X (formerly Twitter) @FDAOncology. Content current as of: 04/18/2024 Regulated Product(s) Drugs Oncology
摘要 待译
On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.