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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

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

Shots:

  • 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 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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