Jazz Pharma's Ziihera Gets USFDA Nod To Treat HER2-Positive Biliary Tract Cancer

The drug zanidatamab-hrii, sold under the brand name Ziihera, is approved for use in previously treated adults with metastatic HER2-positive biliary tract cancer.

HER2 is a protein that stimulates quick growth of cancer cells. Its presence in solid tumor form includes biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers.

The FDA's accelerated approval is based on data from the company's mid-stage 87-patient study, in which patients treated with the drug showed an objective response rate - a measure of treatment effectiveness - of 52%.

Jazz did not immediately respond to a Reuters request for comment on Ziihera's pricing.

"We look forward to advancing research of zanidatamab in BTC and other HER2-expressing solid tumors, with the goal of improving outcomes for more people diagnosed with these difficult-to-treat HER2-positive cancers," said Rob Iannone, Jazz's chief medical officer.

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Jazz and Beigene developed zanidatamab after Jazz acquired exclusive development and commercialization rights for the drug from Zymeworks in 2022.

However, serious adverse reactions occurred in 53% of patients who received Ziihera, the company added on Wednesday. The most common adverse reactions in patients were diarrhea, infusion-related reaction, abdominal pain and fatigue.

The accelerated approval can be converted into a standard approval if the drug shows clinical benefit in a confirmatory trial.

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