BeiGene (BGNE) said Friday the US Food and Drug Administration approved Tevimbra, its drug to treat a form of stomach cancer, in combination with chemotherapy.

Tevimbra, or tislelizumab-jsgr, is approved as a first-line treatment for adults suffering from a certain type of unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, which occurs where the esophagus connects with the stomach, according to the oncology company. The drug is to be used in combination with platinum and fluoropyrimidine-based chemotherapy.

The FDA approval is based on results from BeiGene's phase 3 clinical trial to evaluate the efficacy and safety of the drug. The study met its primary endpoint and the product showed a "statistically significant and clinically meaningful" overall survival benefit, compared with placebo, with a 20% reduction in the risk of death.

The most common adverse reactions to the drug combined with chemotherapy included neutropenia, thrombocytopenia, anemia and fatigue, among others, the company said.

"Today's FDA approval of Tevimbra for the treatment of gastric or gastroesophageal junction cancers in (programmed death ligand 1) positive adult patients marks a significant step forward in our mission to deliver transformative therapies to patients with cancer," BeiGene Chief Medical Officer for Solid Tumors Mark Lanasa said in a statement. "This is the second US approval for Tevimbra this year, underscoring its potential to address critical needs in oncology."

In March, the FDA cleared Tevimbra for the treatment of unresectable or metastatic esophageal squamous cell carcinoma. The European Commission approved Tevimbra in November for first-line treatment of esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma in combination with chemotherapy.

Last month, BeiGene disclosed its intention to change its name to BeOne Medicines.