FDA OKs Zanidatamab Injection for Metastatic HER2+ 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) assessment. The median progression-free survival was 5.5 months (95% CI, 3.7-7.2) via IRC evaluation and 5.4 months (95% CI, 3.6-7.2) 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.¹

References

1. 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
2. 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