首页 News 正文

Baekje Shenzhou Baiyue Ze has received FDA accelerated approval for the treatment of recurrent or refractory follicular lymphoma

小新11
3788 0 0

Recently, BeiGene announced that Baiyue Ze& Reg; Zebutinib has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in combination with the anti-CD20 monoclonal antibody Otuzumab to treat adult patients with recurrent or refractory (R/R) follicular lymphoma (FL) who have undergone at least second-line systemic treatment. This approval also marks the approval of the fifth indication for B-cell malignancy by Baiyue Ze in the United States.
Mehrdad Mobasher, Chief Medical Officer of Haematology at Baekje, said, "The accelerated approval of Baekje is of great significance as it provides the first and only BTK inhibitor treatment option for American follicular lymphoma patients who have failed initial treatment or have relapsed.". Baiyue Ze is the only BTK inhibitor that has shown efficacy in this type of malignant tumor to date. It has been approved for five tumor indications and has the widest coverage of indications among similar drugs worldwide. This fully demonstrates the differentiated clinical characteristics of Baiyue Ze, as well as our unwavering determination to bring this important treatment option to patients worldwide
Baiyue Ze has been approved for multiple indications in 70 markets worldwide, including the United States, the European Union, the United Kingdom, Canada, Australia, China, South Korea, and Switzerland, and is currently developing more indications worldwide. As of now, the Baiyue Ze Global Clinical Development Project has enrolled over 5000 participants in 29 countries and regions.
CandyLake.com 系信息发布平台,仅提供信息存储空间服务。
声明:该文观点仅代表作者本人,本文不代表CandyLake.com立场,且不构成建议,请谨慎对待。
您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

  •   知名做空机构香橼研究(Citron Research)周四(11月21日)在社交媒体平台X上发布消息称,该公司已决定做空“比特币大户”微策略(Microstrategy)这家公司,并认为该公司已经将自己变身成为一家比特币投资基金 ...
    caffycat
    昨天 11:18
    支持
    反对
    回复
    收藏
  •   每经AI快讯,11月20日,文远知行宣布旗下自动驾驶环卫车S6与无人扫路机S1分别在新加坡滨海湾海岸大道与滨海艺术中心正式投入运营。据介绍,这是新加坡首个商业化运营的自动驾驶环卫项目。 ...
    star8699
    3 天前
    支持
    反对
    回复
    收藏
  •   上证报中国证券网讯(记者王子霖)11月20日,斗鱼发布2024年第三季度未经审计的财务报告。本季度斗鱼依托丰富的游戏内容生态,充分发挥主播资源和新业务潜力,持续为用户提供高质量的直播内容及游戏服务,进一步 ...
    goodfriendboy
    3 天前
    支持
    反对
    回复
    收藏
  •   人民网北京11月22日电 (记者栗翘楚、任妍)2024广州车展,在新能源汽车占据“半壁江山”的同时,正加速向智能网联新能源汽车全面过渡,随着“端到端”成为新宠,智能驾驶解决方案成为本届广州车展各大车企竞 ...
    3233340
    昨天 17:06
    支持
    反对
    回复
    收藏
小新11 新手上路
  • 粉丝

    0

  • 关注

    0

  • 主题

    0