China NMPA approves TYVYT for gastric/gastroesophageal junction adenocarcinoma

The National Medical Products Administration (NMPA) has approved the supplemental NDA for TYVYT (sintilimab injection) in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

TYVYT is is the first domestic PD-1 inhibitor approved for the first-line treatment of gastric cancer, and is currently approved for the first-line treatment in five major types of cancers. In China, TYVYT has been approved for the treatment of relapsed or refractory classical Hodgkin’s lymphoma, and nonsquamous non-small cell lung cancer (NSCLC), among other diseases.

This approval was based on the results of a randomised, double-blind, multicenter Phase III clinical trial, evaluating sintilimab in combination with chemotherapy, compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

Dr Hui Zhou, Senior Vice President of Innovent, stated, "The approval of TYVYT by the NMPA for the treatment of gastric cancer represents an important step forward for Innovent to further expand market coverage and is an important milestone for product development and commercial strategy. Data from the ORIENT-16 study demonstrated significant improvement in overall survival in patients with advanced gastric cancer and safety profile was consistent with that observed in previously reported studies of sintilimab.

“Survival benefit and reduction in the risk of death were observed, regardless of PD-L1 expression. Gastric cancer is one of the most common malignancies in China and has different disease characteristics when compared with Western population. Innovent will continue to focus on these unmet medical needs and conduct additional clinical trials to untap the potential of our innovative molecules. We hope to bring more safe and efficacious treatment options to cancer patients both in China and worldwide."

Lina Adams