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

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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