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Mylotarg (gemtuzumab ozogamicin) is an antibody-drug conjugate that combines a CD33-targeting antibody with a cytotoxic agent, delivering targeted chemotherapy directly to CD33-positive leukemia cells.
Mylotarg is FDA-approved for newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older, and for relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older.
Mylotarg originally received accelerated FDA approval in 2000 but was voluntarily withdrawn from the US market in 2010 after a confirmatory trial showed an increased rate of early deaths without added clinical benefit at the original dosing regimen. It was re-approved by the FDA in 2017 using a revised, lower fractionated-dose schedule, which subsequent trials showed improved the benefit-risk balance. This history is noted here for full transparency.
Gemtuzumab ozogamicin binds to CD33 on leukemia cells, is internalized, and releases a cytotoxic payload that damages the leukemia cell's DNA, leading to cell death.
For newly diagnosed AML in combination with chemotherapy, the induction dose is 3 mg/m² (up to one 4.5 mg vial) on Days 1, 4, and 7 with daunorubicin and cytarabine. Dosing for relapsed/refractory disease and single-agent regimens follows a different schedule, as determined by the treating hematologist-oncologist.
Boxed Warning — Mylotarg: Mylotarg carries an FDA boxed warning for hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD, also called sinusoidal obstruction syndrome), reported both as a single agent and as part of combination chemotherapy. Risk is increased in patients with moderate/severe hepatic impairment and in those who receive Mylotarg before or after hematopoietic stem cell transplant (HSCT).
Assess liver function (ALT, AST, total bilirubin, alkaline phosphatase) before each dose and monitor closely after treatment for signs of VOD, including elevated liver enzymes, hepatomegaly, rapid weight gain, and ascites.
Can occur during or shortly after infusion. Premedication and close monitoring are recommended.
Severe and prolonged thrombocytopenia and neutropenia can occur. Monitor blood counts regularly.
Monitor ECG and electrolytes in patients at risk.
Mylotarg can cause fetal harm. Effective contraception is required during treatment and after the final dose.
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, cold-chain 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.
Mylotarg (gemtuzumab ozogamicin) is manufactured by Pfizer. It was re-approved by the FDA in 2017 with a revised dosing regimen after an earlier voluntary market withdrawal in 2010; this history is disclosed here for full transparency.
Import of Mylotarg through a Named Patient Program requires a valid prescription from the treating hematologist-oncologist, confirmation of CD33-positive AML status, and supporting clinical documentation as required by Indian regulatory authorities.
NPP sources Mylotarg directly from Pfizer's authorized supply chain to ensure product authenticity and regulatory compliance.
Mylotarg is sourced through verified, GDP-compliant, cold-chain channels from Pfizer's authorized supply chain to ensure authenticity and quality.
Mylotarg vials should be stored refrigerated at 2°C to 8°C, in the original carton to protect from light.
Once sourced, Mylotarg is packed and transported under continuous cold-chain conditions to preserve product integrity throughout the import process, with tracking and updates provided at each stage of delivery to the patient or treating hospital in India.
Patients across India can access Mylotarg through NPP's regulated import pathway, with hematology-oncology specialists in major cities supporting the treatment process.
Leading hematology-oncology centers in Mumbai support CD33 testing and treatment coordination for Mylotarg access.
Delhi's major cancer hospitals assist patients with diagnostic confirmation and prescription support for Mylotarg.
Bangalore's oncology network offers access to AML treatment planning for eligible patients.
Chennai-based specialists coordinate Mylotarg access alongside comprehensive AML care.
Hyderabad's cancer care institutions support patients pursuing Mylotarg therapy.
Kolkata's oncology centers help coordinate documentation and treatment access for Mylotarg.
Pune-based hematologists assist with diagnosis confirmation and Mylotarg treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Mylotarg.
Kochi's oncology units assist patients with the documentation needed for Mylotarg access.
Chandigarh's cancer care centers support Mylotarg treatment coordination for patients from North India.
Jaipur's oncology specialists help patients navigate the Mylotarg access process.
Lucknow-based cancer centers assist patients pursuing Mylotarg therapy.
Bhubaneswar's oncology institutions support access to Mylotarg for eligible patients.
Guwahati's specialists help coordinate Mylotarg access for patients across the Northeast.
Patients in other cities across India can also access Mylotarg through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 09 September 2026
Sources: FDA • CDSCO
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 09 September 2026
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