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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Source:
Title:

Innovent Announces the China NMPA Approval of TYVYT® (sintilimab injection) in Combination with BYVASDA® (bevacizumab biosimilar injection) as First-Line Therapy for People with Hepatocellular Carcinoma

Published date:
06/27/2021
Excerpt:
Innovent Biologics, Inc. (Innovent)...today announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (HCC).
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Innovent Releases Phase 3 Results of TYVYT® (Sintilimab Injection) in Combination with BYVASDA® (Bevacizumab Biosimilar Injection) as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma at ESMO ASIA Virtual Congress 2020

Published date:
11/23/2020
Excerpt:
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announced...The significantly improved OS and PFS benefits brought by TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) over sorafenib were generally consistent across all subgroups. The combination regimen showed an acceptable safety profile with no new safety signals. With these results, TYVYT® (sintilimab injection) plus BYVASDA® (bevacizumab biosimilar injection) could potentially provide a new option for the first-line treatment of patients with advanced HCC.
Trial ID: