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gemtuzumab ozogamicin (Mylotarg)

Withdrawn from US market June 2010 [2].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: 1) conjugate of recombinant humanized IgG4 kappa with cytotoxic tumor antibiotic calicheamicin 2) 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]

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

Related

acute myeloid leukemia (AML) CD33; myeloid cell surface antigen CD33; sialic acid-binding Ig-like lectin 3; siglec-3; gp67 (SIGLEC3)

General

antineoplastic monoclonal antibody recombinant protein; chimer

References

  1. Kaiser Permanente Northern California Regional Drug Formulary, 2000
  2. FDA MedWatch Mylotarg (gemtuzumab ozogamicin): Market Withdrawal http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216458.htm
  3. Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: 260704 (subscription needed) http://www.prescribersletter.com
  4. 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

Components

gemtuzumab