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Mylotarg Approval History

  • FDA approved: Yes (First approved September 1st, 2017)
  • Brand name: Mylotarg
  • Generic name: gemtuzumab ozogamicin
  • Dosage form: Injection
  • Company: Pfizer Inc.
  • Treatment for: Acute Myeloid Leukemia

Mylotarg (gemtuzumab ozogamicin) is a D33-directed antibody-drug conjugate indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and the treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.

Mylotarg originally received accelerated approval in May 2000 as a stand-alone treatment for older patients with CD33-positive AML who had experienced a relapse. Mylotarg was voluntarily withdrawn from the market after subsequent confirmatory trials failed to verify clinical benefit and demonstrated safety concerns, including a high number of early deaths. The September 2017 approval includes a lower recommended dose, a different schedule in combination with chemotherapy or on its own, and a new patient population.

Development History and FDA Approval Process for Mylotarg

Sep  1, 2017Approval FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia

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