gemtuzumab ozogamicin (Mylotarg)
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Introduction
Withdrawn from US market June 2010[2]. Back on US market with new FDA approval Sept 2017[4]
Indications
- acute myeloid leukemia (AML)
- CD33-positive acute myeloid leukemia (AML)
- newly diagnosed, refractory or relapsed[4]
Monitor
- liver function tests, symptoms of hepatotoxicity[3]
Mechanism of action
- conjugate of recombinant humanized IgG4 kappa with cytotoxic tumor antibiotic calicheamicin
- specifically binds to the CD33 antigen expressed on leukemic blasts in over 80% of patients with acute myeloid leukemia (AML)
Notes
- accelerated approval in 2000
- post-approval clinical trial failed to demonstrate benefit; increased mortality associated with receiving Mylotarg[2]
- FDA approval Sept 2017 for CD33-positive AML[4]
More general terms
Additional terms
- acute myeloid leukemia (AML)
- CD33; myeloid cell surface antigen CD33; sialic acid-binding Ig-like lectin 3; siglec-3; gp67 (SIGLEC3)
Components
References
- ↑ Kaiser Permanente Northern California Regional Drug Formulary, 2000
- ↑ 2.0 2.1 2.2 FDA MedWatch Mylotarg (gemtuzumab ozogamicin): Market Withdrawal http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216458.htm
- ↑ 3.0 3.1 Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260704&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 4.0 4.1 4.2 4.3 Fiore K Mylotarg Back on Market with New FDA Approval. Smaller doses OK'd for certain acute myeloid leukemia indications. MedPage Today. September 01, 2017 https://www.medpagetoday.com/HematologyOncology/Leukemia/67670