Drug · Adc

Gemtuzumab Ozogamicin

CI-DRUG-00000272Explore in graph →NCIt C1806 CHEMBL1201506 CIViC Approved

Regulatory

Approvals (7)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory5 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2020-06-16 (see label)	approved	Jun 16, 2020	openfda
US FDA	Acute Myeloid Leukemia	treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older	approved	Sep 1, 2017	openfda
US FDA	—	. • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older	approved	Sep 1, 2017	openfda
US FDA	—	. • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older	approved	Sep 1, 2017	openfda

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	17	13	17	85	7	CA, EU, US	Sep 1, 2017	1997-02
Leukemia	Approved	Phase 4	17	13	17	83	3	EU, US	Sep 1, 2017	1997-02

Computedclinicaltrialsci-drug-pipeline-v1Stage rules

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
RARA Fusion1
Gemtuzumab Ozogamicin

Clinical trials

Trials with this intervention (89)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 89 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06917911	Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)	recruiting	Phase 2	162	National Cancer Institute (NCI)NIH	1	Sep 29, 2026	clinicaltrials
NCT05564390	MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

Molecule

Record

Kind: Adc
Mechanism: Myeloid cell surface antigen CD33 binding agent; DNA disrupting agent
Targets: 1 gene
UNII: 8GZG754X6M
Aliases: Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, CMC-676, Gemtuzumab, Gemtuzumab Ozogamicin, Gemtuzumab ozogamicina, Gemtuzumab ozogamicine, Gemtuzumab ozogamicin (genetical recombination), Gemtuzumab ozogamicin recombinant, HP67.6-Calicheamicin, L01XC05, Mylotarg, MYLOTARG, WAY-CMA-676

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FX02	GEMTUZUMAB OZOGAMICIN
DIN (Health Canada)	02494388	MYLOTARG