Drug · Monoclonal Antibody

Alemtuzumab

CI-DRUG-00000048Explore in graph →NCIt C1681 CHEMBL1201587 CIViC Approved

Regulatory

Approvals (5)

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

openfdaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2018-11-28 (see label)	approved	Nov 28, 2018	openfda
US FDA	—	Efficacy supplement 2014-11-14 (see label)	approved	Nov 14, 2014	openfda
US FDA	—	Efficacy supplement 2007-09-19 (see label)	approved	Sep 19, 2007	openfda
US FDA	Chronic Lymphocytic Leukemia	CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 )	approved	May 7, 2001	openfda

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	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	5	4	139	5	EU, US	May 7, 2001	2000-01
Leukemia	Approved	Phase 3	2	3	89	2	EU, US	May 7, 2001	2000-01
Non-Hodgkin Lymphoma	Phase3	Phase 3	0	1	38	0	—	—	2000-04
Malignant Cervical Neoplasm	Phase2	Phase 2	1	0	1	0	—

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
TP53 Mutation1
Alemtuzumab	Chronic Lymphocytic Leukemia

Clinical trials

Trials with this intervention (141)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–141 of 141 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
NCT00274976	Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine	completed	Phase 2	—	German CLL Study GroupOTHER	2	Nov 6, 2013	clinicaltrials
NCT00363090	Alemtuzumab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV T-Cell Non-Hodgkin's Lymphoma	unknown

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: CAMPATH-1 antigen inhibitor
Targets: 1 gene
UNII: 3A189DH42V
Aliases: Alemtuzumab, Alemtuzumab (genetical recombination), Allo 647, Anti-CD52 Monoclonal Antibody, Campath, CAMPATH, Campath-1H, CAMPATH-1H, Campath mabcampath, Campath mabcampath, lemtrada, GZ-402673, GZ402673, LDP 03, LDP-03, LDP03, Lemtrada, LEMTRADA, Mabcampath, MabCampath, Monoclonal Antibody Campath-1H

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (2)

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

System	Code	Label
ATC (WHO)	L01XC04	Antineoplastic agents
EMA product	EMEA/H/C/000353	MabCampath

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.