09:04 AM EDT, 07/01/2025 (MT Newswires) -- Jazz Pharmaceuticals ( JAZZ ) said Tuesday the European Commission has granted conditional marketing approval for Ziihera to treat adults with advanced HER2-positive biliary tract cancer that has progressed after prior systemic treatment.

The company said the decision is based on results from the phase 2b Herizon-BTC-01 trial, which achieved its primary endpoint of confirmed objective response rate.

Ziihera, or zanidatamab, is the first HER2-targeted therapy conditionally approved for this indication in the European Union, according to Jazz. Continued approval depends on results from the ongoing phase 3 trial, the company said.