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Withdrawn from US market June 2010[2].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

Monitor

Mechanism of action

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

Components

References

  1. Kaiser Permanente Northern California Regional Drug Formulary, 2000
  2. 2.0 2.1 2.2 FDA MedWatch Mylotarg (gemtuzumab ozogamicin): Market Withdrawal http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216458.htm
  3. 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. 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