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Zymeworks' Zanidatamab Receives the US FDA's Breakthrough Therapy Designation for the Treatment of Biliary Tract Cancer

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Zymeworks' Zanidatamab Receives the US FDA's Breakthrough Therapy Designation for the Treatment of Biliary Tract Cancer

Shots:

  • The US FDA has granted the BTD for zanidatamab in patients with previously-treated HER2 gene-amplified BTC
  • The designation was based on a P-I trial assessing zanidatamab in patients with BTC. The company has initiated a P-II study- which is designed to support accelerated approval based on 1EPs of ORR- and 2EPs of DoR and safety
  • Zanidatamab will now be eligible for accelerated approval- PR and rolling review as well as intensive FDA guidance on an efficient drug development program. The company plans to submit BLA as early as 2022

 ­ Ref: PRNewswire | Image: Wikipedia

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