Biomarker · Gene alteration

TP53 mutation

Somatic TP53 mutations detected by sequencing of tumor tissue or marrow; used mainly as a prognostic and risk-stratification marker across solid and hematologic malignancies.

CI-BIO-00000034TP53 graph →NCIt C118396

Also calledTP53-mutated · p53 mutation · TP53-mutant

Derived

Associated cancers (26)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Malignant Neoplasm	21	21	—	—	0 / 1 / 0 / 19 / 1
Malignant Breast Neoplasm	15	5	10	—	0 / 11 / 1 / 2 / 1
Chronic Lymphocytic Leukemia	7	1	6	—	1 / 6 / 0 / 0 / 0
Malignant Ovarian Neoplasm	7	4	3	—	0 / 5 / 2 / 0 / 0
Gastric Carcinoma

Derived

Drugs with predictive evidence (24)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
MDM2 Inhibitor AMGMDS3	17	1	16	D	1 / 16	Malignant Neoplasm
CisplatinSmall Molecule	9	4	5	B	3 / 5	Gastric Carcinoma, Malignant Gastric Neoplasm,

Curated evidence

Predictive evidence items (52)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 51–52 of 52 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 Deleterious Mutation1
Pazopanib

Regulatory

Approvals mentioning the linked drugs (444)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

health-canada-dpd

Clinical trials

Active trials (1,111)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 558 recruiting · 287 active phase 3 · 5,094 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 951–1,000 of 1,111 active 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
NCT06102824	Organoid-based Functional Precision Therapy for Advanced Breast Cancer(ORIENTA)	recruiting	Phase 2

Literature

Linked publications (58)

Publications linked to the scope gene(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–25 of 58 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Clinical impact of clonal and subclonal TP53, SF3B1, BIRC3, NOTCH1, and ATM mutations in chronic lymphocytic leukemia.
· Blood · 2016 · PMID 26837699 · validated civic_curation pubmed
TP53 mutation and survival in chronic lymphocytic leukemia.
· J Clin Oncol · 2010 · PMID 20697090 · validated civic_curation pubmed
Recurrent mutations refine prognosis in chronic lymphocytic leukemia.
· Leukemia · 2015 · PMID 24943832 · validated civic_curation pubmed
Pooled Analysis of the Prognostic and Predictive Effects of TP53 Comutation Status Combined With KRAS or EGFR Mutation in Early-Stage Resected Non-Small-Cell Lung Cancer in Four Trials of Adjuvant Chemotherapy.
· J Clin Oncol · 2017 · PMID 28453411

TP53 H193R + TP53 R175H1

Pazopanib + VorinostatCombination

Sarcoma

Predictive

Supports Sensitivity Response

accepted

EID7540

In the phase I study of pazopanib and vorinostat in 36 patients with advanced solid tumors, detection of hotspot TP53 mutation was associated with a higher rate of SD ≥6 months/PR, longer median PFS (… (full text at CIViC)

PMID 25669829 · Fu et al., 2015 · Open in CIViC

civic

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE DBL INJ 10MG/ML (DIN 00614335) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 14, 1997	Dec 31, 1985	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE DBL INJ 25MG/ML (DIN 00614343) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 13, 1998	Dec 31, 1985	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE DBL INJ 2.5MG/ML (DIN 00614327) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 13, 1998	Dec 31, 1985	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE SODIUM INJ 25MG/ML (DIN 00519286) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 14, 1997	Dec 31, 1981	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE SODIUM INJ 20MG (DIN 00410195) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 14, 1997	Dec 31, 1977	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE SODIUM INJ 25.0MG/ML (DIN 00321397) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 14, 1997	Dec 31, 1976	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE TAB 2.5MG (DIN 00014915) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 14, 1997	Dec 31, 1955	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as AURO-METHOTREXATE TABLETS (DIN 02448165) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as EUGIA-METHOTREXATE (DIN 02546515) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE INJECTION BP (DIN 02333023) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE TABLETS, USP (DIN 02562839) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as JAMP METHOTREXATE (DIN 02562979) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE (DIN 02283697) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Methotrexate	CA Health Canada	—	Marketed in Canada as METHOTREXATE PF/SA INJECTION (DIN 02377624) under ATC L01BA01 METHOTREXATE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Aug 1, 2018	—	health-canada-dpd
Methotrexate	EU EMA	Acute Lymphoblastic Leukemia	In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.	approved	Mar 29, 2017	ema
Methotrexate	US FDA	—	Efficacy supplement 2024-10-23 (see label)	approved	Oct 23, 2024	openfda
Methotrexate	US FDA	—	Efficacy supplement 2024-10-23 (see label)	approved	Oct 23, 2024	openfda
Methotrexate	US FDA	Mycosis Fungoides	Treatment of adults with mycosis fungoides	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	—	Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) • Treatment of adults with severe psoriasis	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	—	Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) • Treatment of adults with severe psoriasis	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Non-Hodgkin Lymphoma	Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Non-Hodgkin Lymphoma	Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Mycosis Fungoides	Treatment of adults with mycosis fungoides	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Non-Hodgkin Lymphoma	Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	—	Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) • Treatment of adults with severe psoriasis	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	—	Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) • Treatment of adults with severe psoriasis	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Mycosis Fungoides	Treatment of adults with mycosis fungoides	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Mycosis Fungoides	Treatment of adults with mycosis fungoides	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	Non-Hodgkin Lymphoma	Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen	approved	Nov 29, 2022	openfda
Methotrexate	US FDA	—	Efficacy supplement 2021-03-29 (see label)	approved	Mar 29, 2021	openfda
Methotrexate	US FDA	—	. Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy	approved	Apr 25, 2017	openfda
Methotrexate	US FDA	—	. Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy	approved	Apr 25, 2017	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen	approved	Apr 25, 2017	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen	approved	Apr 25, 2017	openfda
Methotrexate	US FDA	—	Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy • Limitation of Use Rasuvo is not indicated for the treatment of neoplastic diseases	approved	Jul 10, 2014	openfda
Methotrexate	US FDA	—	Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy • . • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy • . Limitation of Use Otrexup is not indicated for the treatment of neoplastic diseases	approved	Oct 11, 2013	openfda
Methotrexate	US FDA	—	Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy • . • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy • . Limitation of Use Otrexup is not indicated for the treatment of neoplastic diseases	approved	Oct 11, 2013	openfda
Methotrexate	US FDA	—	Efficacy supplement 1988-04-07 (see label)	approved	Apr 7, 1988	openfda
Methotrexate	US FDA	Head and Neck Squamous Cell Carcinoma	o Treatment of adults with squamous cell carcinoma of the head and neck as a single agent.	approved	Aug 10, 1959	openfda
Methotrexate	US FDA	—	o Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. • Treatment of adults with rheumatoid arthritis (RA). • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). • Treatment of adults with severe psoriasis.	approved	Aug 10, 1959	openfda
Methotrexate	US FDA	Malignant Breast Neoplasm	o Treatment of adults with breast cancer as part of a combination chemotherapy regimen.	approved	Aug 10, 1959	openfda
Methotrexate	US FDA	Osteosarcoma	o Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen.	approved	Aug 10, 1959	openfda
Methotrexate	US FDA	Non-Hodgkin Lymphoma	o Treatment of adult and pediatric patients with non-Hodgkin lymphoma.	approved	Aug 10, 1959	openfda
Methotrexate	US FDA	Meningeal Leukemia	o Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia.	approved	Aug 10, 1959	openfda
Methotrexate	US FDA	Acute Lymphoblastic Leukemia	The following neoplastic diseases for the: o Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen.	approved	Aug 10, 1959	openfda
Mitomycin	CA Health Canada	—	Marketed in Canada as MITOMYCIN FOR INJECTION, USP (DIN 02531941) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 27, 2023	health-canada-dpd