Gemtuzumab ozogamicin
Gemtuzumab ozogamicin (Mylotarg) was the very first ADC: approved in 2000, withdrawn in 2010 for toxicity, and re-approved in 2017 at a lower fractionated dose. Its history is cautionary and instructive.
First-generation ADC with unstable linker and heterogeneous conjugation. Re-approval based on ALFA-0701 with fractionated dosing in CD33+ AML, showing event-free survival benefit with induction chemotherapy.
1.Antibody binds CD33 on the tumour cell surface
- Route
- IV infusion
- Schedule
- Newly diagnosed AML: 3 mg/m² (max 4.5 mg) on days 1, 4, 7 of induction with daunorubicin/cytarabine; relapsed: 3 mg/m² days 1, 4, 7 as single agent
- Dose modifications
- Hold for hepatotoxicity; veno-occlusive disease risk, especially around transplant
- Monitoring
- LFTs before each dose, signs of VOD, blood counts
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Pfizer Oncology Together
- Pfizer RxPathways
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Appraised for
- Untreated de novo CD33-positive AML with standard induction chemotherapy
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA545 · SMC advice: gemtuzumab ozogamicin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 17 May 2000ApprovalUS
Accelerated approval, relapsed CD33+ AML in older patients; first ADC ever approved source
- 21 Jun 2010WithdrawalUS
Voluntary withdrawal after confirmatory trial showed no benefit and excess deaths source
- 1 Sept 2017ApprovalUS
Re-approval at lower fractionated dose for newly diagnosed and relapsed CD33+ AML (ALFA-0701) source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
Pages like this
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