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

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Selumetinib	CA Health Canada	—	Marketed in Canada as KOSELUGO (DIN 02530139) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 3, 2023	health-canada-dpd
Selumetinib	CA Health Canada	—	Marketed in Canada as KOSELUGO GRANULES (DIN 02569736) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Selumetinib	CA Health Canada	—	Marketed in Canada as KOSELUGO GRANULES (DIN 02569744) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Selumetinib	EU EMA	—	Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and older. Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.conditional	approved	Jun 17, 2021	ema
Selumetinib	US FDA	—	Efficacy supplement 2025-11-19 (see label)	approved	Nov 19, 2025	openfda
Selumetinib	US FDA	—	Efficacy supplement 2025-09-10 (see label)	approved	Sep 10, 2025	openfda
Selumetinib	US FDA	—	KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 )	approved	Sep 10, 2025	openfda
Selumetinib	US FDA	—	Efficacy supplement 2024-01-24 (see label)	approved	Jan 24, 2024	openfda
Selumetinib	US FDA	—	KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 )	approved	Apr 10, 2020	openfda
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFENE - 20 (DIN 02296748) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 27, 2011	Oct 29, 2007	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFENE - 10 (DIN 02296721) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 27, 2011	Oct 29, 2007	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFEN (DIN 02237596) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 25, 2016	Sep 28, 1999	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFEN (DIN 02237597) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 25, 2016	Sep 28, 1999	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PMS-TAMOXIFEN (DIN 02237459) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 28, 2016	Dec 1, 1998	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PMS-TAMOXIFEN (DIN 02237460) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 28, 2016	Dec 1, 1998	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE - (10 MG) (DIN 02063778) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 2, 2007	Dec 31, 1996	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE - (20 MG) (DIN 02063751) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 2, 2007	Dec 31, 1996	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as NOLVADEX-D TAB 20MG (DIN 02048485) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Mar 22, 2023	Dec 31, 1995	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as MYLAN-TAMOXIFEN (DIN 02089858) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 9, 2017	Dec 31, 1994	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as MYLAN-TAMOXIFEN (DIN 02088428) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 9, 2017	Dec 31, 1994	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as NOLVADEX TAB 10MG (DIN 02048477) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Apr 1, 2003	Dec 31, 1994	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOPLEX TAB 20MG (DIN 01951947) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 9, 1996	Dec 31, 1992	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOPLEX TAB 10MG (DIN 01951939) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 9, 1996	Dec 31, 1992	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TEVA-TAMOXIFEN (DIN 00851973) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1990	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TEVA-TAMOXIFEN (DIN 00851965) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1990	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE TAB 10MG (DIN 00810444) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 10, 1996	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as APO-TAMOX TAB 20MG (DIN 00812390) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as APO-TAMOX TAB 10MG (DIN 00812404) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE TAB 20MG (DIN 00810452) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 10, 1996	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOFEN 10 (DIN 01926624) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 11, 2011	Dec 31, 1986	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOFEN 20 (DIN 01926632) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 14, 2011	Dec 31, 1986	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as DOM-TAMOXIFEN (DIN 02237598) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 25, 2016	—	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PENTA-TAMOXIFEN TABLETS (DIN 02232552) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled (Unreturned Annual)since Apr 5, 2018	—	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PENTA-TAMOXIFEN TABLETS (DIN 02232551) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled (Unreturned Annual)since Apr 5, 2018	—	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as DOM-TAMOXIFEN (DIN 02237599) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Oct 25, 2016	—	health-canada-dpd
Tamoxifen	US FDA	—	Efficacy supplement 2018-09-25 (see label)	approved	Sep 25, 2018	openfda
Tamoxifen	US FDA	—	To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS)	approved	Oct 29, 2005	openfda
Tamoxifen	US FDA	Malignant Breast Neoplasm	For treatment of adult patients with estrogen receptor-positive metastatic breast cancer	approved	Oct 29, 2005	openfda
Tamoxifen	US FDA	Malignant Breast Neoplasm	For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer	approved	Oct 29, 2005	openfda
Tamoxifen	US FDA	Malignant Breast Neoplasm	To reduce the incidence of breast cancer in adult women at high risk	approved	Oct 29, 2005	openfda
Venetoclax	EU EMA	—	Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL): in combination with acalabrutinib with or without obinutuzumab  in combination with obinutuzumab in combination with ibrutinib   Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.   Venclyxto monotherapy is indicated for the treatment of CLL: in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B cell receptor pathway inhibitor.   Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.	approved	Dec 4, 2016	ema
Vorinostat	CA Health Canada	—	Marketed in Canada as ZOLINZA (DIN 02327619) under ATC L01XH01 VORINOSTAT. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 29, 2009	health-canada-dpd
Vorinostat	US FDA	—	Efficacy supplement 2009-09-23 (see label)	approved	Sep 23, 2009	openfda
Vorinostat	US FDA	Primary Cutaneous T-Cell Non-Hodgkin Lymphoma	ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. ( 1 )	approved	Oct 6, 2006	openfda

Associated cancers (26)

Drugs with predictive evidence (24)

Predictive evidence items (52)

Approvals mentioning the linked drugs (444)

Active trials (1,111)

Linked publications (58)