05:40 AM EST, 11/21/2024 (MT Newswires) -- Jazz Pharmaceuticals ( JAZZ ) said late Wednesday that the US Food and Drug Administration has granted accelerated approval of Ziihera for the treatment of adults with previously treated, inoperable or metastatic HER2-positive biliary tract cancer.

The accelerated approval of the drug, also called zanidatamab-hrii, was based on a phase 2b study in which the drug met its primary endpoint with a 52% objective response rate, the company said.

Continued approval for the treatment may depend on results of an ongoing phase 3 trial evaluating the drug in combination with standard-of-care therapy compared with standard-of-care therapy alone, the company said.

The drug is also being evaluated as a treatment for other tumor types, including gastroesophageal adenocarcinomas and metastatic breast cancer, the company said.

Shares of the company were up more than 3% in recent Thursday premarket activity.

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