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Mylotarg based on Gemtuzumab ozogamicin for CD33-positive acute myeloid leukemia in pediatric patients. FDA has approved


The Food and Drug Administration ( FDA ) has extended the indication of Mylotarg ( Gemtuzumab ozogamicin ) for newly-diagnosed CD33-positive acute myeloid leukemia ( AML ) to include pediatric patients 1 month and older.

Efficacy and safety in the pediatric population were supported by data from AAML0531, a multicenter randomized study of 1,063 patients with newly-diagnosed AML ages 0 to 29 years.
Patients were randomized 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.

The main efficacy outcome measure was event-free survival ( EFS ) measured from the date of trial entry until induction failure, relapse, or death by any cause.
The EFS hazard ratio ( HR ) was 0.84 ( 95% CI: 0.71-0.99 ).
The estimated percentage of patients free of induction failure, relapse, or death at five years was 48% ( 95% CI: 43%-52% ) in the Gemtuzumab ozogamicin plus chemotherapy arm versus 40% ( 95% CI: 36%‑45% ) in the chemotherapy alone arm.
No difference between treatment arms in overall survival was demonstrated.

The most common grade 3 and higher adverse reactions that occurred during induction 1 and intensification 2 in greater than or equal to 5% of patients who received Gemtuzumab ozogamicin were: infection, febrile neutropenia, decreased appetite, hyperglycemia, mucositis, hypoxia, hemorrhage, increased transaminase, diarrhea, nausea, and hypotension. ( Xagena )

Source: FDA, 2020

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