2019年美國(guó)食品藥品監(jiān)督管理局（FDA）共批準(zhǔn)13個(gè)突破性療法新藥上市，其中抗腫瘤藥占比較大，7個(gè)品種分別是用于治療轉(zhuǎn)移性膀胱癌的Balversa、B細(xì)胞淋巴瘤的Polivy、腱鞘巨細(xì)胞瘤的Turalio、非小細(xì)胞肺癌和所有神經(jīng)營(yíng)養(yǎng)因子受體絡(luò)氨酸激酶（NTRK）實(shí)體瘤的Rozlytrek、套細(xì)胞淋巴瘤（MCL）的Brukinsa、尿路上皮癌的Padcev和乳腺癌的Enhertu。血液系統(tǒng)用藥包括Oxbryta、Adakveo。用于罕見病治療的藥物有9個(gè)，主要品種包括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