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Mylotarg FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

FDA Approved: Yes (First approved September 1, 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:

  • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older.
  • treatment of relapsed or refractory CD33-positive AML in adults and 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 Mylotarg was voluntarily withdrawn from the market after subsequent confirmatory trials failed to verify clinical benefit and demonstrated safety concerns, including a high number of early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 included a lower recommended dose, a different schedule in combination with chemotherapy or on its own, and a new patient population.

Development timeline for Mylotarg

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

Further information

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