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NMPA (China) accepts sBLA for tislelizumab, + chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Read time: 1 mins
Published:22nd Jun 2022

BeiGene announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for the company’s anti-PD-1 inhibitor, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1.

The sBLA is supported by data from an interim analysis from the global RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. In China, gastric cancer (GC) has become the third most common cancer and adenocarcinoma represents the major histologic subtype of GC, over 90% of reported cases across the world.

Condition: Gastric /Junction/Esophageal Adenocarcinoma
Type: drug

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