Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized gemtuzumab ozogamicin in combination with cytarabine and daunorubicin for the treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukemia (AML), except acute promyelocytic leukaemia (APL).

This is written in the approval document as:

MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).

Citation

Pfizer Europe MA EEIG. Mylotarg (gemtuzumab ozogamicin) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/mylotarg-epar-product-information_en.pdf. Revised November 2023. Accessed March 20, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	CD33 +	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Gemtuzumab ozogamicin