Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that CD33 + status confers therapeutic sensitivity to Cytarabine, Daunorubicin, Gemtuzumab ozogamicin in patients with Acute Myeloid Leukemia.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2018-04-19	European Medicines Agency	Indication received approval from the European Commission.