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
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