Zymeworks (ZYME) and Jazz Pharmaceuticals (JAZZ) said Thursday they have received accelerated approval for Ziihera from the US Food and Drug Administration to treat adult patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer.
The regulator's approval was based on the HERIZON-BTC-01 trial of Ziihera, which evaluated zanidatamab as a single agent in previously treated HER2-positive biliary tract cancer, the companies added. The trial attained its primary endpoint of a confirmed objective response rate.
The partners are currently carrying out the Phase 3 HERIZON-BTC-302 confirmatory trial to evaluate zanidatamab with standard-of-care therapy against standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.
Zymeworks struck a deal with Jazz's Ireland unit in late 2022 to develop and commercialize zanidatamab throughout all indications in the US, Europe, Japan, and all other regions except for those Asia Pacific territories previously licensed by Zymeworks, the companies said.
Shares of Zymeworks were up 4.5% in recent Thursday premarket activity, while Jazz's stock rose 4.4%.
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