Posted by Michael Wonder on 28 Jun 2022
Innovent and Lilly jointly announce the approval of Tyvyt (sintilimab) by China NMPA in combination with chemotherapy as first-line treatment of advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma
26 June 2022 - Innovent Biologics and Eli Lilly announced that the NMPA of China has approved the supplemental new drug application for Tyvyt (sintilimab) in combination with 5-fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma.
The approval in China was based on the results of a randomised, double-blind, multi-centre Phase III clinical trial (ORIENT-16) evaluating sintilimab in combination with chemotherapy (oxaliplatin and capecitabine), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma.
