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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Vyloy on our secure patient portal to submit your prescription, upload documents and track your approval status.
Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.
Manufacturer / Innovator:
USA
Regulatory Approval:
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Medicines sourced from authorized manufacturers with full batch traceability.
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Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.
Vyloy (zolbetuximab-clzb) is a monoclonal antibody approved by the FDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin 18.2 (CLDN18.2) positive.
Vyloy targets claudin 18.2, a protein highly expressed on the surface of certain gastric and GEJ cancer cells. By binding to CLDN18.2, Vyloy triggers immune-mediated destruction of these cancer cells through mechanisms including antibody-dependent cellular cytotoxicity.
Vyloy is intended for first-line treatment of patients with HER2-negative gastric or GEJ adenocarcinoma whose tumors test positive for CLDN18.2 expression through an approved test, always used in combination with chemotherapy.
The first dose of Vyloy is 800 mg/m² administered intravenously, followed by subsequent doses of either 600 mg/m² every 3 weeks or 400 mg/m² every 2 weeks, always in combination with chemotherapy, until disease progression or unacceptable toxicity.
Vyloy does not carry a formal FDA boxed warning. However, patients and prescribers should be aware of the following important safety information.
Serious hypersensitivity reactions, including anaphylaxis, and serious or fatal infusion-related reactions have been reported. Any-grade hypersensitivity reactions occurred in a meaningful proportion of patients in clinical trials, with severe reactions in a smaller subset. Patients should be monitored during and for at least two hours after infusion.
Severe nausea and vomiting are common with Vyloy. Antiemetic premedication is recommended before each infusion to help manage these effects.
Because Vyloy is always used with fluoropyrimidine- and platinum-containing chemotherapy, the combined toxicity profile of all agents should be considered by the treating oncologist.
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.
Vyloy is manufactured and marketed by Astellas Pharma US, Inc. 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, HER2 status, and CLDN18.2 testing results. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.
As an FDA-approved first-line therapy for CLDN18.2-positive gastric/GEJ adenocarcinoma, Vyloy is sourced through authorized channels and imported under GDP-compliant, cold-chain logistics to preserve product quality throughout transit.
NPP sources Vyloy 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.
Vyloy requires refrigerated storage at 2°C to 8°C, protected from light. 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 Vyloy 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 Vyloy access.
Delhi's major hospitals assist patients with prescription support and documentation for Vyloy.
Bangalore's specialist network offers access coordination for eligible gastric cancer patients seeking Vyloy.
Chennai-based oncology specialists coordinate Vyloy access alongside comprehensive gastric cancer care.
Hyderabad's care institutions support patients pursuing Vyloy therapy.
Kolkata's specialist centers help coordinate documentation and treatment access for Vyloy.
Pune-based specialists assist with prescription support and Vyloy treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Vyloy.
Kochi's specialist units assist patients with the documentation needed for Vyloy access.
Chandigarh's care centers support Vyloy treatment coordination for patients from North India.
Jaipur's specialists help patients navigate the Vyloy access process.
Lucknow-based centers assist patients pursuing Vyloy therapy.
Bhubaneswar's institutions support access to Vyloy for eligible patients.
Guwahati's specialists help coordinate Vyloy access for patients across the Northeast.
Patients in other cities across India can also access Vyloy through NPP's nationwide coordination network.
Last Updated: 15 September 2026
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