Jazz Pharmaceuticals' Ziihera Receives Conditional European Approval for Advanced Biliary Tract Cancer
The approval extends to all European Union member states, as well as Norway, Iceland, and Liechtenstein. Ziihera is authorized as a single agent for adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) BTC who have previously received at least one line of systemic therapy. The recommended dose for zanidatamab is 20mg/kg, administered intravenously every two weeks, until disease progression or unacceptable toxicity.
A biopharmaceutical scientist in their lab, studying a newly-diagnosed therapy-related acute myeloid leukemia. .
The EC's decision was supported by data from the Phase IIb HERIZON-BTC-01 trial, which included 87 participants with previously treated, locally advanced or metastatic HER2-positive BTC. The continuation of this conditional approval depends on further clinical benefits being demonstrated in the ongoing Phase III HERIZON-BTC-302 trial.
Jazz Pharmaceuticals (NASDAQ:JAZZ) identifies, develops, and commercializes pharmaceutical products in the US, Europe, and internationally.
While we acknowledge the potential of JAZZ as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the .
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Disclosure: None. This article is originally published at Insider Monkey.
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