Innovent's Tyvyt (sintilimab) + Byvasda (biosimilar- bevacizumab) Receive the NMPA's Approval as 1L Therapy for Hepatocellular Carcinoma
Shots:
- The approval is based on P-III ORIENT-32 study involves assessing efficacy and safety of Tyvyt + bevacizumab vs sorafenib in 571 patients in a ratio (2:1) as a 1L treatment for patients with advanced or unresectable HCC
- In an interim analysis- the study met the pre-defined efficacy criteria which showed significant improvement in OS and PFS as assessed by IRRC while safety was consistent with previously reported safety profiles of each therapy
- This marks the first regulatory approval of PD-1 inhibitor-based combination therapy as a 1L treatment for HCC and fourth NMPA-approved indication for Tyvyt as well as Byvasda
| Ref: PR Newswire | Image: Innovent
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