FDA Approval Summary: Teclistamab - A Bispecific CD3 T-cell Engager for Patients with Relapsed or Refractory Multiple Myeloma.

IF 10 1区 医学 Q1 ONCOLOGY
Andrea C Baines,Bindu Kanapuru,Jay Zhao,Lauren S L Price,Nan Zheng,Robyn Konicki,Michael L Manning,Brenda J Gehrke,Marc R Theoret,Nicole J Gormley
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引用次数: 0

Abstract

On October 25, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to teclistamab-cqyv (TECVAYLI; Janssen Biotech) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. Substantial evidence of effectiveness was obtained from the MajesTEC-1 trial, a phase 1/2, single-arm, open-label, multi-center study. Patients received step-up doses of teclistamab at 0.06 mg/kg and 0.3 mg/kg followed by 1.5 mg/kg subcutaneously once weekly until disease progression or unacceptable toxicity. An overall response rate of 61.8% was observed, with a complete response or better rate of 28.2%. Cytokine release syndrome (CRS) occurred in 72% of patients and neurologic toxicity (NT) occurred in 57%, including immune effector cell-associated neurotoxicity syndrome (ICANS) in 6%. Due to the risk of CRS and NT, including ICANS, the U.S. prescribing information for teclistamab includes a boxed warning and teclistamab is available only through a restricted program under a risk evaluation and mitigation strategy. Here, we summarize the data and FDA review supporting the accelerated approval of teclistamab, a BCMA-directed bispecific antibody that was the first bispecific CD3 T-cell engager approved for treatment of multiple myeloma.
美国食品和药物管理局(FDA)批准摘要:用于复发性或难治性多发性骨髓瘤患者的双特异性 CD3 T 细胞激活剂--泰克司他单抗。
2022年10月25日,美国食品和药物管理局(FDA)加速批准了teclistamab-cqyv(TECVAYLI;杨森生物技术公司)用于治疗复发性或难治性多发性骨髓瘤成人患者,这些患者此前至少接受过四种疗法,包括蛋白酶体抑制剂、免疫调节剂和抗CD38单克隆抗体。MajesTEC-1试验是一项1/2期、单臂、开放标签、多中心研究,该试验获得了实质性的有效性证据。患者先接受0.06毫克/千克和0.3毫克/千克的泰克司他单抗阶梯剂量,然后再接受1.5毫克/千克的皮下注射,每周一次,直到疾病进展或出现不可接受的毒性。总应答率为61.8%,完全应答或更好的应答率为28.2%。72%的患者出现细胞因子释放综合征(CRS),57%的患者出现神经毒性(NT),包括6%的患者出现免疫效应细胞相关神经毒性综合征(ICANS)。由于存在CRS和NT(包括ICANS)的风险,替卡单抗在美国的处方信息中加入了盒装警告,而且替卡单抗只能通过风险评估和缓解策略下的限制性计划获得。在此,我们总结了支持泰克单抗加速获批的数据和FDA的审查,泰克单抗是一种BCMA导向的双特异性抗体,是首个获批用于治疗多发性骨髓瘤的双特异性CD3 T细胞吸引剂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Clinical Cancer Research
Clinical Cancer Research 医学-肿瘤学
CiteScore
20.10
自引率
1.70%
发文量
1207
审稿时长
2.1 months
期刊介绍: Clinical Cancer Research is a journal focusing on groundbreaking research in cancer, specifically in the areas where the laboratory and the clinic intersect. Our primary interest lies in clinical trials that investigate novel treatments, accompanied by research on pharmacology, molecular alterations, and biomarkers that can predict response or resistance to these treatments. Furthermore, we prioritize laboratory and animal studies that explore new drugs and targeted agents with the potential to advance to clinical trials. We also encourage research on targetable mechanisms of cancer development, progression, and metastasis.
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