FDA OKs Zanidatamab Injection for Metastatic HER2+ Biliary Tract Cancer
Results from the HERIZON-BTC-01 trial led to the approval of zanidatamab for patients with metastatic HER2-positive biliary tract cancer.
The approval is based on results from the phase 2b HERIZON-BTC-01 trial (NCT05152147). Zanidatamab was assessed as a single agent in the aforementioned population.
The FDA has approved zanidatamab-hrii (Ziihera) as a 50 mg/mL injection or intravenous infusion for patients with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer as detected by an FDA-approved test, according to a press release from the developer, Jazz Pharmaceuticals.1
The approval is based on results from the phase 2b HERIZON-BTC-01 trial (NCT05152147).2 Zanidatamab was assessed as a single agent in the aforementioned population.
Topline results from the trial included an objective response rate of 41.3% (95% CI, 30.4%-52.8%) via an independent review committee (IRC). The median progression-free survival was 5.5 months (95% CI, 3.7-7.2) via IRC and 5.4 months (95% CI, 3.607.2) based on investigator assessment.
"The approval of zanidatamab, which previously received breakthrough therapy designation from the FDA for this indication, is an important advance and offers the first and only dual HER2-targeted bispecific antibody and chemotherapy-free treatment for patients living with biliary tract cancer. We look forward to advancing research of zanidatamab in biliary tract cancer and other HER2-expressing solid tumors, with the goal of improving outcomes for more people diagnosed with these difficult-to-treat HER2-positive cancers," Rob Iannone, MD, MSCE, executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals, said in the press release.
References
- Jazz Pharmaceuticals announces U.S. FDA approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). News release. Jazz Pharmaceuticals. November 20, 2024. Accessed November 20, 2024. https://shorturl.at/k6u8A
- Harding JJ, Fan J, Oh DY, et al. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study. Lancet Oncol. 2023;24(7):772-782. doi:10.1016/S1470-2045(23)00242-5
