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ziihera

Generic: zanidatamab-hrii·Code: zanidatamab

ziihera: developed by 2 companies · 1 FDA decision.

ziihera evidence translation

What we can confirm

1 FDA record

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

What is verified about ziihera, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 0 study sponsors

Related indications

Treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC3+) BTCpreviously-treated, unresectable or metastatic HER2-positive (IHC 3+) second-line biliary tract cancer (BTC)

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
Jazz Pharmaceuticals plc (JAZZ)
Treatment of adults with previously treated, unresectable or…
Approved
Zymeworks Inc. (ZYME)
previously-treated, unresectable or metastatic HER2-positive…
Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE ZIIHERA is a bispecific HER2-directed antibody indicated for: Gastroesophageal Adenocarcinoma (GEA) • in combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab-jsgr, as first-line treatment of adult patients with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test. ( 1.1 ) • in combination with fluoropyrim(JAZZ)FDA ↗
BLA761416Type 1 - New Molecular EntityOrphan DrugPriorityOtherInjectable

Frequently asked questions

Who is developing ziihera?

ziihera is being developed by Jazz Pharmaceuticals plc, Zymeworks Inc..

What is ziihera's latest FDA decision?

The most recent tracked FDA decision for ziihera is Approval for 1 INDICATIONS AND USAGE ZIIHERA is a bispecific HER2-directed antibody indicated for: Gastroesophageal Adenocarcinoma (GEA) • in combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab-jsgr, as first-line treatment of adult patients with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test. ( 1.1 ) • in combination with fluoropyrim, dated November 20, 2024.