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 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2017) — Sources
• EMA — Approved (2018) — Sources

Pivotal Clinical Evidence

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

Sources

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