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US Tevimbra Approval Validates BeiGene’s Asia-Heavy Global Trial Approach

Major Milestone For R&D Strategy

 
• By Dexter Jie Yan

BeiGene's first US approval for Tevimbra (tislelizumab), based on an Asia-heavy global study, is expected to pave the way for the biopharma to win two more approvals within 2024.

Asia strategy
BeiGene adopts a “more global approach to clinical trials” for the devleopment of its PD-1 inhibitor. • Source: Shutterstock

Major Chinese firm BeiGene, Ltd. breathed a sigh of relief after the US Food and Drug Administration on 14 March finally approved the company’s anti-PD-1 antibody Tevimbra (tislelizumab), for the treatment of esophageal squamous cell carcinoma (ESCC) in a second-line setting.

The nod came after an extended delay of 20 months as in July 2022 the FDA deferred the original Prescription Drug User Fee Act (PDUFA) action date for the biologics license application (BLA), because COVID-19-related restrictions on internationals travel did not allow the US agency to complete associated on-site inspections of BeiGene’s facilities in China

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