This means that treatment with gemtuzumab ozogamicin
would only get rid of the problematic MDSC wall, leaving the beneficial immune cells relatively untouched.
Pre-transplant risk factors of SOS include liver dysfunction (hepatitis, fibrosis, cirrhosis, etc.), hepatic metastases, history of liver radiotherapy, hepatotoxic agents (including herbal remedies, gemtuzumab ozogamicin
, melphalan, cytosine arabinoside, and cyclophosphamide), infectious attacks, iron overload, history of stem cell transplantation, and advanced age.
FDA Approval: Gemtuzumab ozogamicin
for the treatment of adults with newly-diagnosed CD33-positive acute myeloid leukemia.
IDH1 Ivosidenib Approved Adults with relapsed or refractory AML associated with IDH1 mutation FT-2102 and others Investigational BCL2 Venetoclax Investigational TET2 Vitamin C and Approved (*) AML with low blast count (*) hypomethylating agents CD33 Gemtuzumab ozogamicin
Approved Newly diagnosed CD33-positive AML MDM2 Idasanutlin Investigational (*) US Food and Drug Administration (FDA) approval status (#) Hypomethylating agent (azacitidine) approved for low blast count AML in the US
with or without interleukin 11 in patients 65 years of age or older with untreated acute myeloid leukemia and high-risk myelodysplastic syndrome: comparison with idarubicin plus continuous-infusion, high-dose cytosine arabinoside.
Regulators in the EU have approved Pfizer's (NYSE: PFE) Mylotarg (gemtuzumab ozogamicin
) as a treatment for a certain subset of patients with acute myeloid leukaemia (AML), Pharma Times reported on Wednesday.
Food and Drug Administration has approved MYLOTARG (gemtuzumab ozogamicin
) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.1 MYLOTARG is the first therapy with an indication that includes pediatric AML.
(GO) is a cluster of difference (CD33)-specific antibody and the first immunotherapy agent that has been tested for the treatment of AML.[sup] Several clinical trials have confirmed its antileukemic effect in adult AML.[sup] With an OS of about 30%, GO was approved for the treatment of CD33-positive AML during the first relapse in patients >60 years of age who were not considered for cytotoxic chemotherapy.[sup]
At the time the first antibody-drug conjugate (ADC), gemtuzumab ozogamicin
(Mylotarg[R]) that targets CD33, had already been approved for the treatment of amyloid myeloid leukemia.
Pharmacokinetics of Gemtuzumab Ozogamicin
, an Antibody Targeted Chemotherapy Agent for the Treatment of Patients with Acute Myeloid Leukemia in First Relapse.
is an engineered humanized monoclonal IgG4 antibody directed against the CD33 antigen present on leukemic cells in 80% of patients with AML.