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Innovent Reports sNDA Acceptance of Tyvyt (sintilimab) + Byvasda (biosimilar- bevacizumab) as 1L Therapy for Hepatocellular Carcinoma

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Innovent Reports sNDA Acceptance of Tyvyt (sintilimab) + Byvasda (biosimilar- bevacizumab) as 1L Therapy for Hepatocellular Carcinoma

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  • The acceptance of sNDA is based on P-III ORIENT-32 study assessing in sintilimab + bevacizumab vs sorafenib in 571 subjects in a ratio (2:1) as 1L treatment for patients with advanced HCC
  • The study met the pre-defined efficacy criteria which showed significant improvement in OS and PFS as assessed by IRRC
  • This marks the fifth NDA application of Tyvyt that has been accepted for review by NMPA. Meanwhile- the application also seeks the fourth indication for Byvasda

 ­ Ref: Innovent Bio | Image: Innovent

Click here to­ read the full press release 

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