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.

R287;R961