MYLOTARG gemtuzumab ozogamicin

Drug Class

CD33-directed antibody-drug conjugate

Mechanism

Binds CD33-expressing cells, internalizes, and releases calicheamicin, leading to DNA double-strand breaks and cell death.

Approved Indication

Treatment of newly-diagnosed de novo CD33-positive acute myeloid leukemia (AML) in patients 1 month and older, or relapsed or refractory CD33-positive AML in patients 2 years and older.

What This Means For Patients

Mylotarg (gemtuzumab ozogamicin) is an antibody-drug conjugate directed against CD33, designed to treat acute myeloid leukemia (AML). It delivers calicheamicin directly inside leukemia cells to induce cytotoxic breaks. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2017) — label
• EMA — approved (2018) — source

Pivotal Clinical Evidence

• ALFA-0701 — Castaigne et al., Lancet 2012 (NCT00927498) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761060s004lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/mylotarg