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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