Skip to content
Mylotarg(gemtuzumab ozogamicin)
Mylotarg (gemtuzumab ozogamicin) is an antibody pharmaceutical. Gemtuzumab ozogamicin was first approved as Mylotarg on 2017-09-01. It is used to treat myeloid leukemia acute and myelomonocytic leukemia acute in the USA. It has been approved in Europe to treat myeloid leukemia acute. The pharmaceutical is active against myeloid cell surface antigen CD33.
Download report
Favorite
Drugs Approved for Childhood Cancers
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Mylotarg
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Gemtuzumab ozogamicin
Tradename
Proper name
Company
Number
Date
Products
Mylotarggemtuzumab ozogamicinWyethN-761060 RX2017-09-01
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
mylotargBiologic Licensing Application2020-09-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia acute—D015470C92.0
myelomonocytic leukemia acute—D015479C92.5
Agency Specific
FDA
EMA
Expiration
Code
gemtuzumab ozogamicin, Mylotarg, Wyeth Pharmaceuticals LLC
2024-09-01Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FX: Other monoclonal antibodies and antibody drug conjugates in atc
— L01FX02: Gemtuzumab ozogamicin
HCPCS
Code
Description
J9203
Injection, gemtuzumab ozogamicin, 0.1 mg
Clinical
Clinical Trials
98 clinical trials
View more details
Mock data
Subscribe for the real data
Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.02037142466
ElectrocardiographyD004562EFO_0004327———1—1
PharmacokineticsD010599———1—1
Healthy volunteers/patients————1—1
Intravenous infusionsD007262———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C952178——24
Myelodysplastic syndromesD009190D465143——19
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Promyelocytic leukemia acuteD015473C92.4—4——15
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0—3———3
Megakaryoblastic leukemia acuteD007947C94.213———3
Monocytic leukemia acuteD00794813———3
Myelomonocytic leukemia acuteD015479C92.513———3
Myeloid leukemiaD007951C9223———3
Erythroblastic leukemia acuteD004915EFO_1001257C94.013———3
Philadelphia chromosomeD010677—1———1
Myeloid sarcomaD023981C92.3—1———1
Myelomonocytic leukemia chronicD015477C93.1—1———1
Show 2 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelomonocytic leukemia juvenileD054429C93.32————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameGEMTUZUMAB OZOGAMICIN
INNgemtuzumab ozogamicin
Description
Immunoglobulin G 4 (human-mouse monocional hP67.674-chain anti-human antigen CD 33), disulfide with human-mouse monoclonal hP67.6x-chain, dimer
Classification
Antibody
Drug classmonoclonal antibodies; antibiotics (Micromonospora strains)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID220578-59-6
RxCUI1294580
ChEMBL IDCHEMBL1201506
ChEBI ID—
PubChem CID—
DrugBankDB00056
UNII ID8GZG754X6M (ChemIDplus, GSRS)
Target
Agency Approved
CD33
CD33
Organism
Homo sapiens
Gene name
CD33
Gene synonyms
SIGLEC3
NCBI Gene ID
945
Protein name
myeloid cell surface antigen CD33
Protein synonyms
CD33, CD33 antigen (gp67), CD33 molecule transcript, gp67, Sialic acid-binding Ig-like lectin 3, Siglec-3
Uniprot ID
P20138
Mouse ortholog
Cd33 (12489)
myeloid cell surface antigen CD33 (Q63997)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Additional graphs summarizing 3,312 documents
View more details
Safety
Black-box Warning
Black-box warning for: Mylotarg
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
9,321 adverse events reported
View more details