What is Mylotarg used for?

The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML).

What is Ozogamicin?

Gemtuzumab ozogamicin (GO) is an antibody-drug conjugate consisting of a monoclonal antibody targeting CD33 linked to a cytotoxic derivative of calicheamicin.

When do you use Mylotarg?

Mylotarg is used to treat a certain type (CD33-positive) of newly-diagnosed acute myeloid leukemia in adults and children at least 1 month old. Mylotarg is also used to treat CD33-positive acute myeloid leukemia after other treatments did not work or have stopped working in adults and children at least 2 years old.

Is Mylotarg approved?

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….Development Timeline for Mylotarg.

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

Is Mylotarg available?

Mylotarg is now available on the NHS for previously untreated CD33+ AML patients (except APL) with favourable, intermediate or unknown cytogenetics.

What is azacitidine used to treat?

Azacitidine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Azacitidine is in a class of medications called demethylation agents.

What percentage of AML is CD33 positive?

The majority of AMLs are positive for CD33 and CD123 AML samples of 87.8% (280/319) were positive for CD33, whereas 77.9% (232/298) expressed CD123 (Figures 2a and b).