摘要
2019年美国食品药品监督管理局(FDA)共批准13个突破性疗法新药上市,其中抗肿瘤药占比较大,7个品种分别是用于治疗转移性膀胱癌的Balversa、B细胞淋巴瘤的Polivy、腱鞘巨细胞瘤的Turalio、非小细胞肺癌和所有神经营养因子受体络氨酸激酶(NTRK)实体瘤的Rozlytrek、套细胞淋巴瘤(MCL)的Brukinsa、尿路上皮癌的Padcev和乳腺癌的Enhertu。血液系统用药包括Oxbryta、Adakveo。用于罕见病治疗的药物有9个,主要品种包括Oxbryta、Vyndaqel、Trikafta、Rozlytrek、Polivy、Brukinsa、Turalio、Adakveo、Givlaari。
FDA approved 13 new breakthrough therapy drugs in 2019.Antitumor is still accounted for bigger therapy area.7 antitumor drugs include Balversa tenosynovitis for metastatic bladder cancer,Polivy for B cell lymphoma,Turalio for giant cell tumors,Rozlytrek for non-small cell lung cancer and all NTRK,Brukinsa,for solid tumor cell lymphoma(MCL),Padcev for urothelial carcinoma and Enhertu for breast cancer.Blood system drugs include Oxbryta,Adakveo.There are also a large number of orphan drugs,9 drugs include Oxbryta,Vyndaqel,Trikafta,Rozlytrek,Polivy,Brukinsa,Turalio,Adakveo and Givlaari.
作者
李吉翔
田红
肖桂芝
朱建强
LI Jixiang;TIAN Hong;XIAO Guizhi;ZHU Jianqiang(Tianjin Institute of Pharmaceutical Research Co.,Ltd,Tianjin 300193,China)
出处
《药物评价研究》
CAS
2020年第9期1912-1918,共7页
Drug Evaluation Research
关键词
突破性疗法
FDA
获批新药
抗肿瘤
罕见病
breakthrough therapy designation
FDA
approved new drug market
anti-tumor
rare diseases
