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.

health-canada-dpdRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as MYLOTARG (DIN 02494388) under ATC L01FX02 GEMTUZUMAB OZOGAMICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 11, 2020	health-canada-dpd

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 13 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 51–89 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
NCT03287128	Retrospective Analysis of the Outcome of Patients With Relapsed/Refractory Acute Myeloid Leukemia Included in a Patient Named Program of Gemtuzumab Ozogamicin/Mylotarg®(MYLOR)	unknown	—	300	Versailles HospitalOTHER	1	Jan 24, 2018	clinicaltrials
NCT00673153	Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

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 16 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