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Association details:
Biomarker:No biomarker
Cancer:Esophageal Squamous Cell Carcinoma
Drug:Tyvyt (sintilimab) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Title:

Innovent and Lilly Jointly Announce the Approval of TYVYT® (sintilimab injection) by China NMPA in Combination with Chemotherapy as First-Line Treatment for Esophageal Squamous Cell Carcinoma

Published date:
06/20/2022
Excerpt:
Innovent Biologics, Inc...and Eli Lilly and Company...announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for TYVYT (sintilimab injection) in combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)...The new approval was based on the interim analysis of ORIENT-15, a global randomized, double-blind, multi-center Phase 3 clinical trial – which evaluated sintilimab in combination with chemotherapy...
Secondary therapy:
cisplatin + 5-fluorouracil; cisplatin + bisphosphonate bound paclitaxel