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

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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from China

More from Asia