Jazz Pharmaceuticals receives CHMP positive opinion for Ziihera (zanidatamab) for the treatment of advanced HER2-positive biliary tract cancer

Jazz Pharmaceuticals plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.

“This positive CHMP opinion is a welcome step for physicians and patients in Europe who face a critical unmet need in HER2-positive biliary tract cancers, a rare and aggressive group of cancers with poor prognosis and limited treatment options,” said Dr. Robert Iannone, executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. “If approved, zanidatamab would be the first HER2-targeted therapy licensed for this difficult-to-treat cancer in the EU, marking an important milestone in addressing this unmet need. We look forward to the European Commission’s decision and the opportunity to provide a new treatment option for patients.”

The CHMP recommendation is based on data from the Phase IIb HERIZON-BTC-01 trial, which evaluated zanidatamab in previously treated, inoperable, and advanced or metastatic HER2-positive BTC. The CHMP’s recommendation will now be reviewed by the European Commission which has the authority to approve medicines in all EU Member States, Iceland, Norway, and Liechtenstein, and is expected to make a final decision.

See citations- 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: 772 doi: 10.1016/S1470-2045(23)00242-5

Pant S et al. Zanidatamab in Previously Treated HER2-Positive Biliary Tract Cancer: Overall Survival and Longer Follow-Up From the Phase 2b HERIZON-BTC-01 Study. J Clin Oncol. 2024; 42(16_suppl). Abstract 4091.