接受Darvias治疗的患者肿瘤大小在1期临床试验中的变化(图片来源:参考资料[2])
这一批准是基于在多个亚洲国家进行的2期临床试验的结果。
参考资料:
[1] Solasia Pharma: DARVIAS® Injection 135mg (Generic Name: DARINAPARSIN /Development Code: SP-02) Approved in Japan. Retrieved June 20, 2022, from https://www.businesswire.com/news/home/20220620005030/en/
[2] Ogura et al., (2021). Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea, Jpn J Clin Oncol, DOI: 10.1093/jjco/hyaa177
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