New drug for acute myeloid leukemia (AML) ! FDA approves Pfizer Mylotarg: Treatment of 1 month, new diagnosis, CD33 positive pediatric patients!

, June 17, 2020 /
BIOON/ -- The U.SFood and Drug Administration (
FDA) has approved the expansion of
the-targeted cancer drug Mylotarg (gemtuzumab ozogamicin) in patients with cd3-positive acute myel
oidleukemia (AML) patients with newdiagnosedThe approval was approved through the priority review processnow, Mylotarg can be used to treat newdiagnose
scd33-positive AML (children and adults with a age of 1 month), relapse or refractive CD33-positive AML (children and adults with age of 2 years)mylotarg's efficacy and safety in the pediatric population are supported by a study data from AAML0531 (NCT00372593)This is a multicenter, randomized study of 1,063 new diagnosed AML patients aged 0-29 In the study, these patients were randomly assigned to 5 cycles of chemotherapy alone or treated in combination with Mylotarg (dose 3 mg/m2, induced 1 6th day administration, enhanced 2 7th day administration) treatment The main therapeutic outcome indicators range from the beginning of the trial to the non-event survival (EFS) of induced failure, recurrence, or total death data show that the EFS risk ratio (HR) of Mylotarg-chemotherapy combination therapy and chemotherapy single-drug therapy was 0.84% (95% CI: 0.71-0.99) In the Mylotarg plus chemotherapy group, the estimated percentage of patients without induction failure, recurrence or death within 5 years was 48% (95% CI: 43-52%), compared with 40% (95% CI: 36%-45%) in the individual chemotherapy group There was no difference in the total lifetime (OS) of the 2 treatment groups patients treated with Mylotarg, the most common adverse reactions at level 3 in induced 1 and fortified 2 were infection, decreased febrile neutrophils, decreased appetite, high blood sugar, mucositis, hypoxia, bleeding, elevated transaminase, diarrhea, nausea, and hypotension Mylotarg is the first AML treatment to target CD33, an antibody drug conjugated (ADC) made from the cytotoxic agent calicheamicin and a monoclonal antibody that targets CD33 CD33 is an antigen protein that is expressed on Up to 90% of patients' AML cells When Mylotarg binds to the CD33 antigen on the cell surface, it is absorbed into the cell, releasing kachimycin, causing the cell to die in the United States, Mylotarg received accelerated approval in 2000 as a single drug therapy (high dose) for CD33-positive AML adults who experienced the first relapse, age of 60 years, and are not suitable for other cytotoxic chemotherapy However, in 2010, Pfizer voluntarily withdrew Mylotarg from the U.S market after it failed to show clinical efficacy in a validation trial and had a higher incidence of fatal toxicity compared to chemotherapy But in the Japanese market, Mylotarg is still on sale and available to patients through sympathetic medication programs because the need for the drug in patients with acute myeloid leukemia (AML) has not yet been met, clinicians are still interested in evaluating Mylotarg at different doses and courses of treatment With Pfizer's support, these independent researchers conducted clinical trials and gained more information about mylotarg's effectiveness and safety September 2017, Mylotarg received u.S FDA approval: (1) cd33-positive AML adult patients with new diagnosis ; (BiovalleyBioon.com) original origin: FDA
ofes gemtuzumab ozogamicin for CD33-positive AML in pediatric patients