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Applications Heavily Reliant On Foreign Data Get Positive Signals In US FDA Reviews

 
• By Dexter Jie Yan and Derrick Gingery

Agency has notably rejected some NDAs that relied solely on Chinese data, but a positive advisory committee for Geron’s proposed anemia treatment imetelstat and approval for BeiGene’s anti-PD-1 antibody Tevimbra suggest that using a lot of foreign data could be OK.

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

The US Food and Drug Administration is now famously skeptical of applications composed solely of foreign data, especially in oncology, and especially when that data is from China. But two recent review developments suggest that applications with a heavy, but not total reliance, on foreign data could win acceptance.

On March 14, China-based BeiGene, Ltd. received approval for its anti-PD-1 antibody Tevimbra (tislelizumab), for the treatment of esophageal squamous cell carcinoma (ESCC) in a second-line setting.

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