Drug · Monoclonal Antibody

Tremelimumab

CI-DRUG-00000611Explore in graph →NCIt C49085 CHEMBL2108658 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.

emaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Lung Non-Small Cell Carcinoma	Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.	withdrawn	Feb 20, 2023	ema

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 21 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 3	67	24	19	188	5	CA, EU, US	Oct 21, 2022	2003-08
Malignant Liver Neoplasm	Approved	Phase 3	27	13	7	35	1	US	Oct 21, 2022	2008-12
Malignant Kidney Neoplasm	Phase3	Phase 3	2	1	1	8	0	—	—	2006-11
Malignant Bladder Neoplasm	Phase2	Phase 2	3	0	0	9	0

Curated evidence

Clinical evidence (3)

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

civicCuratedShowing 1–3 of 3 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
KEAP1 Mutation1
Chemotherapy + Durvalumab Regimen

Clinical trials

Trials with this intervention (194)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 151–194 of 194 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
NCT03081923	Durvalumab Alone or With Tremelimumab in Refractory Germ Cell Tumors(APACHE)	terminated	Phase 2	36	Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoOTHER	1	May 14, 2021	clinicaltrials
NCT02311361	Immune Checkpoint Inhibition (Tremelimumab and/or MEDI4736) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Cytotoxic T-lymphocyte protein 4 inhibitor
Targets: 1 gene
UNII: QEN1X95CIX
Aliases: Anti-CTLA4 Human Monoclonal Antibody CP-675,206, CP 675, CP675, CP 675206, CP-675,206, CP-675206, CP675206, Imjudo, Immunoglobulin G2, Anti-(Human CTLA-4 (Antigen)) (Human Monoclonal CP-675206 Clone 11.2.1 Heavy Chain) Disulfide With Human Monoclonal CP-675206 Clone 11.2.1 Light Chain, Dimer, PF-06753388, Ticilimumab, TICILIMUMAB, Tremelimumab, Tremelimumab-actl, Tremelimumab astrazeneca, Tremelimumab (genetical recombination)

Data updated 29 minutes agoSource updated unknown

Identifiers

Codes (5)

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

System	Code	Label
ATC (WHO)	L01FX20	TREMELIMUMAB
DIN (Health Canada)	02541009

High2
Durvalumab + TremelimumabCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID12799 This is part of a open-label phase 3 trial, NEPTUNE, that examined therapeutic response to first-line durvalumab plus tremelimumab in patients with metastatic non-small cel lung cancer (NSCLC). 823 pa… (full text at CIViC) PMID 36240972 · de Castro et al., 2023 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID12042 In this randomized phase II trial, 180 patients with microsatellite stable (MSS) colorectal cancer were treated with either a combination of durvalumab and tremelimumab (D+T; n=119) or best supportive… (full text at CIViC) PMID 38727700 · Loree et al., 2024 · Open in CIViC	civic