FDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for recurrent or metastatic head and neck squamous cell carcinoma
正文 · 中文译文
FDA授予amivantamab与透明质酸酶-lpuj加速批准，用于复发或转移性头颈部鳞状细胞癌 信息资源 | 已批准药物 2026年11月5日，美国食品药品监督管理局（FDA）授予amivantamab与透明质酸酶-lpuj（Rybrevant Faspro，Janssen Biotech, Inc.）加速批准，用于患有复发或转移性头颈部鳞状细胞癌（HNSCC）的成人患者，这些患者的疾病在含铂化疗和抗PD-(L)1抗体治疗期间或之后出现进展。amivantamab与透明质酸酶-lpuj不适用于HPV相关的口咽鳞状细胞癌（OPSCC）患者。 Rybrevant Faspro的完整处方信息将发布在Drugs@FDA上。 疗效与安全性 疗效在OrigAMI-4（NCT06385080）中进行了评估，该研究是一项多中心、开放标签、多队列临床试验。主要疗效人群包括102例复发或转移性HNSCC患者。根据p16检测结果，主要疗效人群未包括HPV相关OPSCC患者。符合条件的患者须既往接受过含铂化疗和抗PD-(L)1抗体治疗。患者接受基于体重的单药amivantamab与透明质酸酶-lpuj皮下注射，每3周一次，按推荐剂量给药，直至疾病进展或出现不可接受的毒性。 主要疗效结局指标为总缓解率（ORR）和缓解持续时间（DOR），由盲态独立中心审查（BICR）根据RECIST v1.1判定。ORR为42%（95% CI：32%，52%），其中56%的缓解者DOR ≥ 6个月。 amivantamab与hyaluronidase-lpuj单药的处方信息包括超敏反应和给药相关反应、间质性肺病（ILD）/肺炎、皮肤不良反应、眼毒性以及胚胎-胎儿毒性的警告和注意事项。 推荐剂量 推荐剂量基于体重。具体给药信息见处方信息。 本审查在Project Orbis框架下进行，该项目为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查提供了框架。本次审查中，FDA与巴西卫生监管局（ANVISA）、加拿大卫生部（HC）、以色列卫生部（IMoH）以及新加坡卫生科学局（HSA）合作。相关申请可能正在其他监管机构进行提交程序或仍处于审查中。 本审查使用了Assessment Aid，这是申请人自愿提交以促进FDA评估的工具。 本申请获得了优先审查资格。amivantamab与hyaluronidase-lpuj获得了突破性疗法认定。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。 如需获得研究性肿瘤产品单患者IND方面的协助，医疗保健专业人员可致电OCE的Project Facilitate，电话号码240-402-0004，或发送电子邮件至OncProjectFacilitate@fda.hhs.gov。 内容更新日期： 11/05/2026 受监管产品 药物 肿瘤学
正文 · 英文原文
FDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for recurrent or metastatic head and neck squamous cell carcinoma Resources for Information | Approved Drugs On November 5, 2026, the Food and Drug Administration granted accelerated approval to amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. Amivantamab and hyaluronidase-lpuj is not indicated for patients with oropharyngeal squamous cell carcinoma (OPSCC) that is HPV-associated. Full prescribing information for Rybrevant Faspro will be posted on Drugs@FDA. Efficacy and Safety Efficacy was evaluated in OrigAMI‑4 (NCT06385080) a multicenter, open-label, multi-cohort clinical trial. The primary efficacy population included 102 patients with recurrent or metastatic HNSCC. The primary efficacy population did not include patients with HPV-associated OPSCC based on p16 testing results. Eligible patients were required to have received previous treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody. Patients received single agent weight-based amivantamab and hyaluronidase-lpuj subcutaneously every 3 weeks at the recommended dose until disease progression or unacceptable toxicity. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), determined by blinded independent central review (BICR) according to RECIST v1.1. ORR was 42% (95% CI: 32%, 52%), with 56% of responders having a DOR ≥ 6 months. The prescribing information for amivantamab and hyaluronidase-lpuj as a single agent includes warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease (ILD)/pneumonitis, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity. Recommended Dosage The recommended dose is based on body weight. See the prescribing information for the specific dosing information. 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 Brazilian Health Regulatory Agency (ANVISA), Health Canada (HC), Israel Ministry of Health (IMoH), and Singapore's Health Sciences Agency (HSA). The applications may be undergoing the submission process or still be under review at the other regulatory agencies. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted priority review. Amivantamab and hyaluronidase-lpuj received breakthrough therapy designation. 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: 11/05/2026 Regulated Product(s) Drugs Oncology
摘要 待译
FDA granted accelerated approval to amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody.