罗氏ADC组合获FDA批准 今日,罗氏旗下基因泰克公司宣布,美国FDA批准抗体偶联药物(ADC)Polivy(polatuzumab vedotin)与利妥昔单抗加环磷酰胺、多柔比星和泼尼松(R-CHP)联用,一线治疗弥漫性大B细胞淋巴瘤(DLBCL)患者。新闻稿指出,Polivy组合是近20年来FDA批准一线治疗DLBCL的首款新疗法,具有延缓疾病进展,降低患者和医疗...
Polatuzumabvedotin-piiq是CD79b定向的抗体-药物偶联物(ADC),由三个部分组成:1)对人CD79b特异的人源化免疫球蛋白G1(IgG1)单克隆抗体;2)小分子抗有丝分裂剂MMAE;3)蛋白酶可切割的接头马来酰亚胺基己酰基-缬氨酸-瓜氨酸-对氨基苄氧基羰基(mc-vc-PAB),其将MMAE共价附于泊洛妥珠单抗。 Polatuzumab vedotin-...
Recent findings: Polatuzumab vedotin recently received its first FDA approval in combination with bendamustine and rituximab for the treatment of patients with relapsed or refractory DLBCL. Polatuzumab vedotin has been evaluated and is being studied in combinations with chemoimmunotherapy, immunomodulating...
实体瘤的微环境等因素导致药物难以渗透,就这一层面而言,血液肿瘤的可及性更好,这也是为什么ADC药物会先在血液肿瘤领域取得突破的关键因素所在[美国食品药品监督管理局(FDA)在2011年批准Brentuximab Vedotin(商品名:Adcetris)治疗霍奇金淋巴瘤和间变性大细胞淋巴瘤]。 受益于过去几十年间的抗体改造技术,人源化和全人源...
【汇众医疗】罗氏旗下基因泰克淋巴瘤药物 Polatuzumab vedotin 获 FDA 优先审评资格 $罗氏控股(RHHBY)$罗氏旗下基因泰克今天宣布, FDA已经接受了该公司的生物技术许可申请( BLA ),并批准了与苯达莫司汀联合利妥昔单抗联合治疗复发或难治性(R/R)弥漫性大B细胞淋巴瘤的优先审评。 查看全文网页链接...
U.S. Food and Drug Administration (FDA). FDA D.I.S.C.O. Burst Edition: FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma. Drugs. Silver Spring, MD: FDA; April 19, 2023....
Polivy (polatuzumab vedotin-piiq) 产品说明书 Proprietary & Confidential © 2023 Magellan Health, Inc. Polivy® (polatuzumab vedotin-piiq) (Intravenous) Document Number: IC-0482 Last Review Date: 05/04/2023 Date of Origin: 07/01/2019 Dates Reviewed: 07/2019, 09/2019, 07/2020, 12/...
List of Approved drugs containing Polatuzumab Vedotin listed with Health Canada in the Drug Product Database (DPD)
Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. BACKGROUND: Hodgkin's lymphoma and anaplastic large-cell lymphoma are the two most common tumors expressing CD30. Previous attempts to target the CD30 anti... A Younes,NL Bartlett,JP Leonard,... - 《N Engl J Med》 被引量...
Polatuzumab vedotin plus bendamustine and rituximab (pola + BR) received regulatory approvals for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) based on primary results from the randomized arms of the GO29365 study. After the randomized phase, 106 additional patients received pola...