2018年8月9日，美国食品与药物管理局（FDA）批准Poteligeo（mogamulizumab-kpkc）静脉注射疗法，用于在至少进行一次之前的系统性治疗后，治疗复发或难治性蕈样肉芽肿病（mycosis fungoides，MF）或者Sézary综合征（Sézary syndrome，SS）成人患者。这项批准为MF患者提供了新的治疗选择，同时是FDA首次批准专门针对SS的药物。  “MF和SS是罕见、难以治疗的非霍奇金淋巴瘤类型，这项批准解决了这些患者的未满足医疗需求，”FDA肿瘤学卓越中心主任兼FDA药物评估和研究中心血液及肿瘤产品办公室代理主任Richard Pazdur博士说，“我们致力于继续加快这类靶向疗法的开发和审查，为患者提供有意义的治疗。”   非霍奇金淋巴瘤是一种始于淋巴细胞的癌症，淋巴细胞是人体免疫系统的一部分。   MF和SS是非霍奇金淋巴瘤的两种类型，在这两种疾病中淋巴细胞会癌变并影响皮肤。MF约占所有皮肤淋巴瘤的一半，会引起发痒的红色皮疹和皮肤损伤，并会扩散到身体其他部位。SS是一种罕见形式的皮肤淋巴瘤，会影响血液和淋巴结。   Poteligeo是一种结合到某些癌细胞上CCR4蛋白质（CC趋化因子受体4型）的单克隆抗体。   此次批准以一项包括372名复发性MF或SS患者的临床试验为基础，试验中患者接受Poteligeo或一种被称为vorinostat的化疗治疗。与接受vorinostat治疗的患者（中值为3.1个月）相比，接受Poteligeo治疗患者（中值7.6个月）的无进展生存期（癌症没有生长的情况下患者存活的时间）更长。   Poteligeo治疗的最常见副作用包括皮疹、输注相关反应、疲劳、腹泻、肌肉骨骼疼痛和上呼吸道感染。   Poteligeo治疗的严重警告包括皮肤毒性风险、输注反应、感染、自身免疫问题（免疫细胞攻击体内其他细胞或器官）和该药治疗后使用捐献干细胞（同种异体）的干细胞移植并发症。   FDA授予这项申请优先审查和突破性疗法资格认定。Poteligeo还获得了孤儿药资格认定，该资格认定为辅助和鼓励罕见病药物开发提供了激励。 商标和其他名：Poteligeo，mogamulizumab-kpkc 类别: 抗肿瘤单克隆抗体 给药用途 成年儿童 剂型& 规格 注射的溶液 ·20mg/5mL，单次-剂量小瓶(4mg/mL) 蕈样真菌病[Mycosis Fungoides]或Sézary综合征 CC趋化因子受体类型4 指向- (CCR4)单克隆抗体适用为成年有复发或难治单克隆抗体蕈样真菌病 或Sézary综合征至少1次全身治疗后。 首个28-天疗程在天1，8，15，和22 1mg/kg IV，然后各随后疗程的天1和15直至疾病进展或不能接受的毒性。 输注历时至少60min 见给药 剂量修饰 皮肤学毒性 ·轻度(级别1) 皮疹发生: 考虑局部甾体。 ·中度或严重(级别2或3)皮疹发生: 中断治疗和给予至少2周的局部皮质激素; 如皮疹改善至级别≤1，恢复治疗 ·危及生命(级别4) 皮疹或对任何Stevens-Johnson综合征(SJS)或毒性表皮坏死溶解(TEN): 永久地终止治疗如SJS或TEN被怀疑，停止治疗和不要恢复 除非 SJS或TEN已被排除和皮肤反应已恢复至 ≤级别1 输注反应 •如发生一个输注反应给予预先药物(如，苯海拉明[diphenhydramine]，扑热息痛)对随后输注 ·轻度至严重(级别1至3): 暂时中断输注和治疗挣扎着; 症状解决后，在开始输注在一个减低输注速率(至至少 50%); 如反应复发和是不能处置，终止输注。 ·危及生命(级别4)输注反应: 永久地终止 肾受损 ·CrCl <90mL/min: 未观察奥临床上意义药代动力学变化 肝受损 ·轻度(总胆红素 ≤ULN和AST，或总胆红素 <1-1.5xULN和任何AST)或中度(总胆红素>1.5-3 x ULN和任何AST):未观察到临床上显著药代动力学变化 ·严重(总胆红素 >3 倍ULN和任何AST): 未知 FDA approved: Yes (First approved August 8, 2018) Brand name: Poteligeo Generic name: mogamulizumab-kpkc Dosage form: Injection Company: Kyowa Kirin, Inc. Treatment for: Mycosis Fungoides; Sézary Syndrome Poteligeo (mogamulizumab-kpkc) is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL). Dosage Forms and Strengths Injection: 20 mg/5 mL (4 mg/mL) solution in a single-dose vial. Dosage and Administration Poteligeo is administered as an intravenous infusion over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle, and on days 1 and 15 of each subsequent cycle. Warnings and Precautions Poteligeo may cause serious side effects that can be severe or life-threatening. The following adverse reactions may require additional treatment and/or withholding or discontinuation of Poteligeo: Dermatological Toxicity: Patients need to contact their healthcare provider immediately if they experience new or worsening skin rash. Treatment should be temporarily interrupted for moderate or severe skin rashes and permanently discontinued for a life-threatening rash. Infusion Reactions: Patients need to contact their healthcare provider immediately for signs or symptoms of infusion reactions. Treatment should be temporarily interrupted for any infusion reaction and permanently discontinued for any life-threatening infusion reaction. Infections: Patients need to contact their healthcare provider if they experience fever or other signs of infection. Infections should be monitored and treated promptly. Autoimmune Complications: Patients need to notify their healthcare provider of any history of autoimmune disease. Treatment should be interrupted or permanently discontinued as appropriate. Complications of Allogeneic Hematopoietic Stem Cell Transplantation after Poteligeo: Patients need to be aware of the potential risk of post-transplant complications. Patients should be monitored for severe acute graft-versus-host disease (GVHD) and steroid-refractory GVHD. Females of Reproductive Potential: Females who are able to become pregnant should use an effective method of birth control during treatment with Poteligeo and for at least three months after the last dose. Adverse Reactions The most common adverse reactions (reported in ≥20% of patients) were rash, infusion related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. Development History and FDA Approval Process for Poteligeo