FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma
正文 · 中文译文
FDA批准cosibelimab-ipdl用于转移性或局部晚期皮肤鳞状细胞癌 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12月13日，美国食品药品监督管理局批准cosibelimab-ipdl（Unloxcyt，Checkpoint Therapeutics， Inc.），一种程序性死亡配体-1（PD-L1）阻断抗体，用于不适合根治性手术或根治性放疗的转移性皮肤鳞状细胞癌（mCSCC）或局部晚期CSCC（laCSCC）成人患者。 Unloxcyt的完整处方信息将发布在Drugs@FDA上。 疗效与安全性 疗效在Study CK-301-101（NCT03212404）中评估，这是一项多中心、多队列、开放标签试验，纳入109例不适合根治性手术或根治性放疗的mCSCC或laCSCC患者。若患者存在以下任一情况则被排除：活动性或疑似自身免疫性疾病、治疗前6个月内接受过同种异体移植、既往接受过抗PD-1/PD-L1阻断抗体或其他免疫检查点抑制剂治疗、未控制或显著的心血管疾病、ECOG PS ≥ 2，或感染HIV、乙型肝炎或丙型肝炎。 主要疗效结局指标为独立中心审查委员会（IRC）根据RECIST第1.1版评估的客观缓解率（ORR）和缓解持续时间（DOR）。对于具有外部可见靶病灶且无法通过放射学影像评估的laCSCC患者，ORR由IRC对数字摄影的评估（WHO标准）确定。mCSCC患者（n=78）的ORR为47%（95% CI：36，59），laCSCC患者（n=31）的ORR为48%（95% CI：30，67）。mCSCC患者的中位DOR未达到（范围：1.4+，34.1+），laCSCC患者的中位DOR为17.7个月（范围：3.7+，17.7）。 不良反应 最常见的不良反应（≥10%）为疲乏、肌肉骨骼疼痛、皮疹、腹泻、甲状腺功能减退、便秘、恶心、头痛、瘙痒、水肿、局部感染和尿路感染。 cosibelimab-ipdl的推荐剂量为1，200 mg，每3周经60分钟静脉输注给药一次，直至疾病进展或出现不可接受的毒性。 本审评使用了评估辅助工具（Assessment Aid），这是申请人自愿提交的材料，旨在促进FDA的评估。 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。 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 上关注肿瘤学卓越中心：@FDAOncology。 内容截至： 2024年12月13日 受监管产品 药物 肿瘤学
正文 · 英文原文
FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma 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Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals On December 13, 2024, the Food and Drug Administration approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. Full prescribing information for Unloxcyt will be posted on Drugs@FDA. Efficacy and Safety Efficacy was evaluated in Study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label trial in 109 patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation. Patients were excluded if they had any of the following: active or suspected autoimmune disease, allogeneic transplant within 6 months prior to treatment, prior treatment with anti-PD-1/PD-L1 blocking antibodies or other immune checkpoint inhibitor therapy, uncontrolled or significant cardiovascular disease, ECOG PS ≥ 2, or infection with HIV, hepatitis B, or hepatitis C. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as assessed by an independent central review committee (IRC) according to RECIST version 1.1. For patients with laCSCC with externally visible target lesions not assessable by radiologic imaging, ORR was determined by ICR assessments of digital photography (WHO criteria). ORR was 47% (95% CI: 36, 59) for patients with mCSCC (n=78) and 48% (95% CI: 30, 67) for patients with laCSCC (n=31). Median DOR was not reached (range: 1.4+, 34.1+) in patients with mCSCC and 17.7 months (range: 3.7+, 17.7) in patients with laCSCC. Adverse Reactions The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritis, edema, localized infection, and urinary tract infection. The recommended cosibelimab-ipdl dose is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity. 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: 12/13/2024 Regulated Product(s) Drugs Oncology
摘要 待译
On December 13, 2024, the FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics, Inc.), a programmed death ligand-1 (PD-L1) blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC).