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Manufacturer / Innovator:
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Regulatory Approval:
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Ziihera (zanidatamab-hrii) is a bispecific HER2-targeted antibody approved by the FDA for two indications: in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab, as first-line treatment of adults with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastroesophageal adenocarcinoma; and as a single agent for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer.
Ziihera binds to two distinct sites on the HER2 protein simultaneously, providing a dual-binding mechanism that leads to enhanced HER2 receptor blockade and immune-mediated destruction of HER2-overexpressing cancer cells, in tumor types with high HER2 expression.
Ziihera is used in two distinct HER2-positive cancer settings: first-line gastroesophageal adenocarcinoma in combination with chemotherapy and immunotherapy, and previously treated biliary tract cancer as a single agent, both requiring confirmed HER2 IHC 3+ status.
For gastroesophageal adenocarcinoma, dosing is weight-based: patients under 70 kg receive 1,800 mg every 3 weeks or 1,200 mg every 2 weeks; patients 70 kg or more receive 2,400 mg every 3 weeks or 1,600 mg every 2 weeks. For biliary tract cancer, the dose is 20 mg/kg every 2 weeks.
Boxed Warning — Ziihera: Ziihera, in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab, can cause severe diarrhea, including life-threatening and fatal cases. Antidiarrheal prophylaxis is recommended during the first treatment cycle. Ziihera can also cause embryo-fetal harm when administered during pregnancy; effective contraception should be used during treatment.
Diarrhea should be managed with antidiarrheal medicines and supportive care as clinically indicated. Ziihera should be interrupted, dose-reduced, or discontinued based on severity.
Cardiac function should be assessed before and during treatment, as left ventricular dysfunction has been reported.
Infusion-related reactions have been reported. Patients should be monitored during and after infusion, with treatment interrupted or slowed as needed.
Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.
Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.
Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.
Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.
Ziihera is marketed by Jazz Pharmaceuticals, with the molecule originally developed by Zymeworks. It is sourced through authorized distribution channels for patients seeking named-patient import into India.
Patients typically need a valid prescription from a treating oncologist confirming diagnosis and HER2 IHC 3+ testing results. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As an FDA-approved therapy for HER2-positive gastroesophageal adenocarcinoma and biliary tract cancer, Ziihera is sourced through authorized channels and imported under GDP-compliant, cold-chain logistics to preserve product quality throughout transit.
NPP sources Ziihera directly from authorized pharmaceutical distributors to ensure product authenticity and full traceability. Every shipment is handled under Good Distribution Practice (GDP) conditions from origin to the patient's doorstep.
Ziihera requires refrigerated storage at 2°C to 8°C in its original carton, and must not be frozen. NPP maintains a continuous, monitored cold chain throughout transit.
Once documentation and regulatory approvals are in place, delivery timelines are communicated transparently at the time of quotation, accounting for import clearance and last-mile cold-chain logistics to the patient's city.
Patients across India can access Ziihera through NPP's regulated import pathway, with oncology specialists in major cities supporting the treatment process.
Leading hospitals in Mumbai support oncology care coordination and documentation for Ziihera access.
Delhi's major hospitals assist patients with prescription support and documentation for Ziihera.
Bangalore's specialist network offers access coordination for eligible HER2-positive cancer patients seeking Ziihera.
Chennai-based oncology specialists coordinate Ziihera access alongside comprehensive gastrointestinal cancer care.
Hyderabad's care institutions support patients pursuing Ziihera therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Ziihera.
Pune-based specialists assist with prescription support and Ziihera treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Ziihera.
Kochi's specialist units assist patients with the documentation needed for Ziihera access.
Chandigarh's care centers support Ziihera treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Ziihera access process.
Lucknow-based centers assist patients pursuing Ziihera therapy.
Bhubaneswar's institutions support access to Ziihera for eligible patients.
Guwahati's specialists help coordinate Ziihera access for patients across the Northeast.
Patients in other cities across India can also access Ziihera through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 15 September 2026
Sources: FDA
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 15 September 2026
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