Ziihera (zanidatamab)
- Region
- 🇪🇺 EU
- Active substance
- zanidatamab
- Company
- Jazz Pharmaceuticals Ireland Limited
- Status
- Authorised
- Therapeutic area
- Biliary Tract Neoplasms
- CHMP opinion
- Fri 25 Apr 2025
- EU approval
- Fri 27 Jun 2025
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/006380
- ATC
- L01FD07
- Official record
- www.ema.europa.eu
Indication
Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).
Regulatory milestones
Ziihera: PDUFA target action date (first-line HER2+ gastroesophageal adenocarcinoma (GEA))
Jazz Pharmaceuticals plc (JAZZ); zanidatamab-hrii; sBLA; status: set; "Food and Drug Administration (FDA) granted Priority Review and set Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2026 for supplemental Biologics License Application (sBLA) for zanidatamab containing combinations in first-line (1L) gastroesophageal adenocarcinoma (GEA)."; filed 2026-08-03 · source
Ziihera: PDUFA target action date (first-line HER2-positive unresectable locally advanced or metastatic gastric, GEJ, or gastroesophageal adenocarcinoma (G)
Zymeworks Inc. (ZYME); zanidatamab-hrii; sBLA; status: set; "FDA acceptance with Priority Review of Supplemental Biologics License Application (sBLA) for zanidatamab in first-line HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA); PDUFA target action date of August 25, 2026 • China’s NMPA has accepted the sBLA for zanidatamab;…"; filed 2026-05-07 · source
Follow Ziihera
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.