FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma
正文 · 中文译文
FDA新闻稿 FDA加速批准头颈部鳞状细胞癌新疗法 更多新闻公告 即时发布： 2026年11月5日 美国食品药品监督管理局（FDA）今日加速批准Rybrevant Faspro（amivantamab and hyaluronidase-lpuj）用于治疗既往接受含铂化疗和免疫治疗后疾病进展的复发或转移性头颈部鳞状细胞癌（HNSCC）成人患者。HNSCC是一种侵袭性强、危及生命的疾病，对有效疗法存在高度未满足需求。 Rybrevant Faspro不适用于与人乳头瘤病毒（HPV）相关的口咽部鳞状细胞癌患者的治疗。 该批准基于试验结果，显示与目前获批疗法相比，对药物产生应答的患者百分比超过两倍。这是10年来首次批准用于既往接受过含铂化疗的复发或转移性HNSCC患者的药物。 “今日的批准代表着头颈部鳞状细胞癌患者向前迈出的有意义的一步，该疾病历史上治疗选择有限且结局仍然不佳，”FDA肿瘤学卓越中心主任、医学博士Angelo De Claro表示。“该疗法为患者及其医生提供了一种新选择，有可能对人们的生活产生真正的改变。” 加速审批计划允许基于替代终点或中间终点，对治疗严重疾病并满足未满足医疗需求的药物进行更早批准。在本例中，Rybrevant Faspro的加速审批是基于总缓解率和缓解持续时间授予的。由于尚未确认这是否会转化为长期结局中具有临床意义的获益，FDA已要求开展确证性研究以验证并描述临床获益。 在一项纳入102例复发或转移性头颈部鳞状细胞癌（HNSCC）患者的开放标签、多中心临床试验中，Rybrevant Faspro的总缓解率为42%，即这些患者观察到肿瘤缩小或消失。在有缓解的患者中，56%的缓解持续六个月或更长时间。目前获批疗法的总缓解率约为20%或更低，且结局较差。 作为单药使用的处方信息包括对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、眼毒性以及对未出生婴儿造成伤害的警告和注意事项。 FDA授予Rybrevant Faspro该适应症的突破性疗法认定。该批准授予Janssen Biotech, Inc. 媒体： FDA征求意见 202-690-6343 消费者： 888-INFO-FDA 美国食品药品监督管理局（FDA）是美国卫生与公众服务部下属的一个机构，通过确保人用和兽用药物、疫苗及其他人用生物制品以及医疗器械的安全性、有效性和保障性来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、辐射发射电子产品以及烟草产品监管的安全与保障。 ### 内容截至： 2026年11月05日 受监管产品 药物 关注FDA 在X上关注@US_FDA 在Facebook上关注FDA 在X上关注@FDAMedia
正文 · 英文原文
FDA News Release FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma More Press Announcements For Immediate Release: November 05, 2026 The U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. HNSCC is an aggressive, life-threatening disease for which there is a high unmet need for effective therapies. Rybrevant Faspro is not indicated as a treatment for patients with oropharyngeal squamous cell carcinoma that is associated with human papillomavirus (HPV). Approval was based on trial results showing that more than double the percentage of patients responded to the drug compared to currently approved therapies. This is the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy. “Today’s approval represents a meaningful step forward for patients with head and neck squamous cell carcinoma, a disease where treatment options have historically been limited and outcomes remain poor,” said Angelo De Claro, M.D., director of the FDA’s Oncology Center of Excellence. “This therapy offers patients and their physicians a new option with the potential to make a real difference in people’s lives.” The Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on surrogate or intermediate endpoints. In this case, accelerated approval of Rybrevant Faspro was granted based on overall response rate and duration of response. Since it is not yet confirmed whether this will translate into a clinically meaningful benefit in long-term outcomes, the FDA has required confirmatory studies to verify and describe clinical benefit. In an open-label, multicenter clinical trial involving 102 patients with recurrent or metastatic HNSCC, Rybrevant Faspro had an overall response rate of 42%, meaning these patients saw their tumor either decrease in size or disappear. Of those patients who had a response, 56% had a response lasting six months or longer. Currently approved therapies are associated with an overall response rate of around 20% or less and poor outcomes. The prescribing information for use 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 harm to an unborn baby. The FDA granted Rybrevant Faspro Breakthrough Therapy designation for this indication. The approval was granted to Janssen Biotech, Inc. Media: FDA Request for Comment 202-690-6343 Consumer: 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. ### Content current as of: 11/05/2026 Regulated Product(s) Drugs Follow FDA Follow @US_FDA on X Follow FDA on Facebook Follow @FDAMedia on X
摘要 待译
The U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherap