Jazz Pharmaceuticals receives FDA accelerated approval for Ziihera in HER2+ biliary tract cancer

Jazz Pharmaceuticals plc

FDA approved Ziihera (zanidatamab-hrii) for adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC.
Approval based on 52% objective response rate and median duration of response of 14.9 months by independent central review.
First and only dual HER2-targeted bispecific antibody approved for this indication in the U.S.
Continued approval contingent on confirmatory Phase 3 trial HERIZON-BTC-302; Boxed Warning for embryo-fetal toxicity.
Investor webcast scheduled for December 11, 2024, to discuss clinical data and commercialization strategy.

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