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FDA Grants Accelerated Approval to Ziihera® (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer

NextEdge Admin

22 Nov 2024

2 min 27 sec

Biliary Tract Cancer,HER2-targeted bispecific antibody,oncology

Jazz Pharmaceuticals announced FDA accelerated approval of Ziihera® (zanidatamab-hrii) for adults with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer (BTC), based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months. Approval is contingent upon further clinical validation through the Phase 3 HERIZON-BTC-302 confirmatory trial, evaluating zanidatamab with standard-of-care therapy.

BTC is a rare and aggressive cancer with limited treatment options. Ziihera is the first dual HER2-targeted bispecific antibody offering a chemotherapy-free option for this population. HERIZON-BTC-01 trial data demonstrated Ziihera’s efficacy, achieving significant tumor response rates in 62 patients with HER2-positive BTC. Results were presented at ASCO 2023, with follow-up data showing improved outcomes at ASCO 2024.

"Ziihera represents a crucial advancement for HER2-positive BTC patients," said Dr. Rob Iannone, Jazz's Chief Medical Officer. Dr. James Harding of Memorial Sloan Kettering highlighted its promise as a targeted therapy, while Stacie Lindsey of the Cholangiocarcinoma Foundation emphasized its potential to enhance quality of life for patients and families.

In HERIZON-BTC-01, serious adverse reactions occurred in 53% of patients, including biliary obstruction, infection, and sepsis. The most common side effects were diarrhea, abdominal pain, and fatigue, with one fatal case of hepatic failure reported. Ziihera carries a boxed warning for embryo-fetal toxicity, underscoring the need for effective contraception during treatment.

Beyond BTC, zanidatamab is being explored for HER2-positive gastroesophageal adenocarcinomas and metastatic breast cancer in Phase 3 trials, broadening its potential impact in HER2-driven malignancies.