Posted by Michael Wonder on 16 Jun 2020
FDA approves gemtuzumab ozogamicin for CD33-positive AML in paediatric patients
16 June 2020 - Today the FDA extended the indication of gemtuzumab ozogamicin (Mylotarg, Wyeth Pharmaceuticals) for newly-diagnosed CD33-positive acute myeloid leukaemia to include paediatric patients 1 month and older.
Efficacy and safety in the paediatric population were supported by data from AAML0531 (NCT00372593), a multicenter randomised study of 1,063 patients with newly-diagnosed acute myeloid leukaemia ages 0 to 29 years.
Patients were randomised to 5-cycle chemotherapy alone or with gemtuzumab ozogamicin (3 mg/m2) administered once on day 6 in Induction 1 and once on day 7 in Intensification 2.
