FDA Grants Accelerated Approval to Ziihera for the Treatment of HER2-Positive Biliary Tract Cancer

Jazz Pharmaceuticals plc has announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by independent central review (ICR).

• Continued approval for this indication may be contingent upon verification and description of
  clinical benefit in a confirmatory trial.
• Biliary Tract Cancer, including gallbladder cancer and intrahepatic and extrahepatic
  cholangiocarcinoma, account for <1% of all adult cancers globally and are often associated with a
  poor prognosis.

Source: Jazz Pharmaceuticals plc