FDA批准Monjuvi用于复发性、难治性滤泡性淋巴瘤

亿欧网
Jun 24

美国食品药品监督管理局(FDA)已批准Monjuvi(tafasitamab-cxix),一种人源化的Fc修饰溶细胞CD19靶向单克隆抗体,用于治疗复发或难治性滤泡性淋巴瘤的成年患者。该批准基于3期临床试验inMIND的结果,该试验显示,与安慰剂组相比,Monjuvi组在无进展生存期(PFS)方面取得了具有统计学意义和临床意义的显著改善。然而,在接受Monjuvi联合利妥昔单抗和来那度胺治疗的患者中,有33%发生了严重不良反应,包括严重感染、肾功能不全、第二原发恶性肿瘤以及发热性中性粒细胞减少症。

责任编辑:栎树

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10