Second FDA approval for BeiGene’s Tevimbra in 2024

The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1), Sino-China biotech BeiGene (HKEX: 06160) revealed today.

“Today’s FDA approval of Tevimbra for the treatment of gastric or gastroesophageal junction cancers in PD-L1 positive adult patients marks a significant step forward in our mission to deliver transformative therapies to patients with cancer,” said Dr Mark Lanasa, chief medical officer, solid tumors at BeiGene. “This is the second US approval for Tevimbra this year, underscoring its potential to address critical needs in oncology. We remain deeply grateful to the patients, clinicians, and researchers whose commitment and courage have made this progress possible - and we look forward to building on this momentum in 2025.”

Tevimbra (tislelizumab) sales for the third quarter of this year totaled $163 million, representing growth of 13% compared to the prior-year period.