Antibodies to watch in 2020
Antibodies to watch in 2020
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DOI：
10.1080/19420862.2019.1703531
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发表时间：
2020-01-01
期刊：
影响因子：
5.3
通讯作者：
Reichert, Janice M.
中科院分区：
文献类型：
--
作者：
Kaplon, Helene;Muralidharan, Mrinalini;Reichert, Janice M.
年度“值得关注的抗体”系列的 2020 年分期记录了 2019 年批准的、美国或欧盟监管审查中的抗体疗法，以及截至 2019 年 11 月*的后期临床研究中的抗体疗法。目前，共有 5 种新型抗体疗法（romosozumab、risankizumab、polatuzumab vedotin、brolucizumab 和 crizanlizumab）在美国或欧盟获得首次批准，并有 13 种新型抗体疗法（eptinezumab、teprotumumab、enfortumab vedotin、isatuximab、 [fam-]trastuzumab deruxtecan、inebilizumab、leronlimab、sacituzumab govitecan、satralizumab、narsoplimab、tafasitamab、REGNEB3 和 naxituximab）正在这些代表抗体治疗的主要市场的地区接受审查。截至 2019 年 11 月，有 79 种新型抗体正在后期临床研究中接受评估。在这 79 种抗体中，有 39 种正在接受非癌症适应症的后期研究评估，其中 2 种（ublituximab、pamrevlumab）也处于癌症适应症的后期研究中。开发 39 种药物中的 7 种（tanezumab、aducanumab、evinacumab、etrolizumab、sutimlimab、anifrolumab 和 teplizumab）的公司已表示，他们可能于 2020 年在美国或欧盟提交上市申请。在后期研究的 79 种抗体中，40 种正在接受癌症治疗评估，其中可能有 9 种（belantamab） mafodotin、oportuzumab monatox、margetuximab、dostarlimab、spartalizumab、131I-omburtamab、loncastuximab tesirine、balstilimab 和 zalifrelimab）可能会在 2019 年底或 2020 年进入监管审查。总体而言，生物制药行业的抗体治疗药物临床管道十分稳健，应能提供持续供应 未来为患者提供创新产品。 *截至 2019 年 12 月 18 日的重要更新说明：1) 美国食品和药物管理局于 2019 年 12 月 18 日加速批准 enfortumab vedotin-ejfv (Padcev)，使 2019 年美国或欧盟首次批准的新型抗体疗法总数达到 6 个； 2）欧盟委员会于2019年12月9日批准romosozumab； 3）欧洲药品管理局对brolucizumab发表积极意见； 4）Sesen Bio于2019年12月6日启动滚动生物制剂许可申请（BLA）； 5）葛兰素史克提交了belantamab mafodotin的BLA； 6) GSK3359609（一种人源化 IgG4 抗 ICOS 抗体）在头颈鳞状细胞癌患者中的 3 期研究 (NCT04128696) 状态从尚未招募更新为招募。
This 2020 installment of the annual 'Antibodies to Watch' series documents the antibody therapeutics approved in 2019 and in regulatory review in the United States or European Union, as well as those in late-stage clinical studies, as of November 2019*. At this time, a total of 5 novel antibody therapeutics (romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, and crizanlizumab) had been granted a first approval in either the US or EU, and marketing applications for 13 novel antibody therapeutics (eptinezumab, teprotumumab, enfortumab vedotin, isatuximab, [fam-]trastuzumab deruxtecan, inebilizumab, leronlimab, sacituzumab govitecan, satralizumab, narsoplimab, tafasitamab, REGNEB3 and naxituximab) were undergoing review in these regions, which represent the major markets for antibody therapeutics. Also as of November 2019, 79 novel antibodies were undergoing evaluation in late-stage clinical studies. Of the 79 antibodies, 39 were undergoing evaluation in late-stage studies for non-cancer indications, with 2 of these (ublituximab, pamrevlumab) also in late-stage studies for cancer indications. Companies developing 7 (tanezumab, aducanumab, evinacumab, etrolizumab, sutimlimab, anifrolumab, and teplizumab) of the 39 drugs have indicated that they may submit a marketing application in either the US or EU in 2020. Of the 79 antibodies in late-stage studies, 40 were undergoing evaluation as treatments for cancer, and potentially 9 of these (belantamab mafodotin, oportuzumab monatox, margetuximab, dostarlimab, spartalizumab, 131I-omburtamab, loncastuximab tesirine, balstilimab, and zalifrelimab) may enter regulatory review in late 2019 or in 2020. Overall, the biopharmaceutical industry's clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future. *Note on key updates through December 18, 2019: 1) the US Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev) on December 18, 2019, bringing the total number of novel antibody therapeutics granted a first approval in either the US or EU during 2019 to 6; 2) the European Commission approved romosozumab on December 9, 2019; 3) the European Medicines Agency issued a positive opinion for brolucizumab; 4) Sesen Bio initiated a rolling biologics license application (BLA) on December 6, 2019; 5) GlaxoSmithKline submitted a BLA for belantamab mafodotin; and 6) the status of the Phase 3 study (NCT04128696) of GSK3359609, a humanized IgG4 anti-ICOS antibody, in patients with head and neck squamous cell carcinoma was updated to recruiting from not yet recruiting.