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Gemtuzumab ozogamicin (Mylotarg) is an anti-CD33 antibody linked to the DNA-cutting payload calicheamicin, the first ADC approved, in 2000 for relapsed acute myeloid leukaemia. An unstable linker and no benefit in a confirmatory trial led to withdrawal in 2010; it returned in 2017 at a lower fractionated dose, with liver toxicity, including veno-occlusive disease, its defining risk.
Gemtuzumab ozogamicin (Mylotarg) is a humanised anti-CD33 IgG4 antibody linked through an acid-labile hydrazone to calicheamicin, a DNA cleaver that causes double-strand breaks, at a drug-to-antibody ratio of about 2 to 3. It was the very first ADC, approved in 2000 for relapsed CD33-positive AML, but this first-generation design had an unstable linker and heterogeneous conjugation, and it was withdrawn in 2010 after a confirmatory trial showed no benefit and excess deaths. Re-approval in 2017 was based on ALFA-0701, in which fractionated dosing (3 mg/m² on days 1, 4 and 7 with induction chemotherapy) improved event-free survival in CD33-positive AML. Hepatotoxicity including veno-occlusive disease, haemorrhage and infection are the key risks, so liver tests are checked before each dose. Its history shows that schedule and linker chemistry can decide the fate of a sound target.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Anti-CD33 humanised IgG4 with calicheamicin; DNA double-strand cleavage. Connects to CD33.
1.Antibody binds CD33 on the tumour cell surface
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Often given inpatient with induction chemotherapy (Part A).
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA545 · SMC advice: gemtuzumab ozogamicin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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For patients with CD33+ AML in first relapse 60 years of age or older and not candidates for cytotoxic chemotherapy
Accelerated approval, relapsed CD33+ AML in older patients; first ADC ever approved source
Voluntary withdrawal after confirmatory trial showed no benefit and excess deaths source
For patients with CD33+ AML in first relapse 60 years of age or older and not candidates for cytotoxic chemotherapy
Withdrawn: the indication came off the label 11.5 years after its accelerated approval.
Re-approval at lower fractionated dose for newly diagnosed and relapsed CD33+ AML (ALFA-0701) source
| Region | Year | Indication |
|---|---|---|
| US | 2000 | Relapsed CD33+ AML (withdrawn 2010) |
| US | 2017 | Newly diagnosed and relapsed CD33+ AML |
| Adverse event |
|---|
| Haemorrhage |
| Infection |
| Hepatotoxicity including veno-occlusive disease |
| Thrombocytopenia |
| Infusion reactions |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Gemtuzumab ozogamicin" OR ABSTRACT:"Gemtuzumab ozogamicin" OR TITLE:"Mylotarg" OR ABSTRACT:"Mylotarg") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gemtuzumab ozogamicin, not a curated reading list.
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