Cancer Discov. 2019 Oct;9(10):1332. doi: 10.1158/2159-8290.CD-NB2019-102. Epub 2019 Aug 30.
The FDA recently approved fedratinib for myelofibrosis, making it just the second drug approved for the disease, as well as the second approved JAK inhibitor. The approval was based on the phase III JAKARTA trial, in which the drug significantly reduced symptoms compared with a placebo. However, the drug comes with a Boxed Warning for encephalopathy.
美国食品药品监督管理局（FDA）最近批准了fedratinib用于治疗骨髓纤维化，这使其成为第二种被批准用于该疾病的药物，也是第二种被批准的JAK抑制剂。该批准基于III期JAKARTA试验，在该试验中，与安慰剂相比，该药物显著减轻了症状。然而，该药物带有关于脑病的黑框警告。
