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 1–50 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 Mutation8
Alemtuzumab

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 51–100 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
NCT07271355	Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial	recruiting	Phase 3

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 Wildtype6
Chemotherapy	Esophageal Carcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID906 Patients with p53 wild type (as defined by low expression and/or wild-type tp53 gene) had a higher response rate to chemotherapy-based treatment (total major response [MR]: risk ratio [RR] = 1.09, 95 … (full text at CIViC) PMID 23515910 · Zhang et al., 2013 · Open in CIViC	civic
RG7112	Leukemia	Predictive	B	Supports Sensitivity Response	3	accepted	EID2965 Phase I Trial of RG7112 in 116 heavily pretreated patients with AML, ALL, CML, CLL, sCLL demonstrated sustained clinical improvement and induction of TP53 target genes in subset of patients with wild … (full text at CIViC) PMID 26459177 · Andreeff et al., 2016 · Open in CIViC	civic
Adjuvant Chemotherapy	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID1149 Pooled analysis of TP53 mutations (exons 5-8) from 4 randomized trials (IALT, JBR10, CALGB-9633 and ANITA, 1209 patients, median follow-up 5.5 years) of platinum-based adjuvant chemotherapy (ACT) vers… (full text at CIViC) PMID 26899019 · Ma et al., 2016 · Open in CIViC	civic
Capecitabine + Cetuximab + OxaliplatinCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID875 In this retrospective biomarker analysis of the EXPERT-C trial, patients with TP53 wild-type status had a statistically significant better progression free survival (PFS) (89.3% vs 65.0% at 5 years; h… (full text at CIViC) PMID 24957073 · Sclafani et al., 2014 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	4	accepted	EID2964 MDM2 Inhibitor screen in a panel of 260 cancer cell lines with well characterized TP53 status shows that only cancer cell lines with unaltered TP53 may be sensitive to MDM2 Inhibitor. PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic
Rebemadlin	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	4	accepted	EID2963 MDM2 Inhibitor Nutlin-3a induced senescence in presence of functional TP53 in murine primary fibroblasts, oncogenically transformed fibroblasts, and fibrosarcoma cell lines. Cells lacking functional T… (full text at CIViC) PMID 17671205 · Efeyan et al., 2007 · Open in CIViC	civic

TP53 R273C2
Cisplatin + Etoposide + MitomycinCombination	Gastric CarcinomaALIAS	Predictive	C	Does Not Support Sensitivity Response	3	accepted	EID2292 A female patient taking part in a 25 patient gastric cancer trial was diagnosed at age 46, and received preoperative high dose chemotherapy (HDCT). Japanese Society for Gastric Cancer Response Score w… (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID4881 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 Inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 Inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic

TP53 Y220C2
Cisplatin + Etoposide + MitomycinCombination	Gastric CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID2306 A male patient taking part in a 25 patient gastric cancer trial was diagnosed at age 50, harbored a TP53 mutation and received preoperative high dose chemotherapy (HDCT). Japanese Society for Gastric … (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID4884 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 Inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 Inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic

TP53 R175H4
EAP Protocol	Gastric CarcinomaALIAS	Predictive	C	Supports Sensitivity Response	—	accepted	EID2310 In a study of 25 patients with advanced gastric cancer, mutations in TP53 were identified in 32% of primary tumors. TP53 mutations were associated with an improved response to preoperative treatment o… (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
Doxorubicin	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	3	accepted	EID319 Breast tumors in a mouse model with R172H mutation (homologous to human R175H) are more responsive to doxorubicin than breast tumors with wild type TP53. PMID 22698404 · Jackson et al., 2012 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	3	accepted	EID4880 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	3	accepted	EID10074 Subset of 58 cancer cell lines with unaltered TP53 is sensitive to MDM2 inhibitor AMGMDS3. None of 115 cancer cell lines with TP53 mutation and absence of WT allele are sensitive to MDM2 inhibitor. TP… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic

TP53 Deleterious Mutation4
RG7112	Leukemia	Predictive	B	Supports Resistance	3	accepted	EID2966 Phase I Trial of MDM2 inhibitor RG7112 in 116 patients with AML, ALL, CML, CLL, sCLL demonstrated sustained clinical improvement and induction of TP53 target genes in subset of patients with wild type… (full text at CIViC) PMID 26459177 · Andreeff et al., 2016 · Open in CIViC	civic
Adjuvant Chemotherapy	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID1148 Pooled analysis of TP53 mutations (exons 5-8) from 4 randomized trials (IALT, JBR10, CALGB-9633 and ANITA) of platinum-based adjuvant chemotherapy (ACT) versus observation (OBS). Patients with TP53wt … (full text at CIViC) PMID 26899019 · Ma et al., 2016 · Open in CIViC	civic
MDM2 Inhibitor AMGMDS3	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID2967 MDM2 Inhibitor screen in a panel of 260 cancer cell lines with well characterized TP53 status shows that only cancer cell lines with unaltered TP53 may be sensitive to MDM2 Inhibitor AMGMDS3, while th… (full text at CIViC) PMID 25730903 · Saiki et al., 2015 · Open in CIViC	civic
Rebemadlin	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	4	accepted	EID2968 MDM2 Inhibitor Nutlin-3a induced senescence in presence of functional TP53 in murine primary fibroblasts, oncogenically transformed fibroblasts, and fibrosarcoma cell lines. TP53 mutant cells lacking … (full text at CIViC) PMID 17671205 · Efeyan et al., 2007 · Open in CIViC	civic

TP53 Overexpression2
Cisplatin + Etoposide + MitomycinCombination	Malignant Gastric Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID2799 In a Phase II trial of 25 patients with metastaic gastric cancer, patients received preoperative high dose chemotherapy (HDCT) consisting of etoposide, cisplatin and mitomycin. Patients with greater t… (full text at CIViC) PMID 14514923 · Bataille et al., 2003 · Open in CIViC	civic
Carboplatin + CisplatinSubstitutes	Malignant Ovarian Neoplasm	Predictive	B	Supports Resistance	3	accepted	EID3013 In a study involving patients with invasive ovarian carcinoma who had undergone surgery, a subset of 73 patients were classified via response to platinum-based chemotherapy as sensitive or resistant/r… (full text at CIViC) PMID 11595686 · Reles et al., 2001 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Mitomycin	CA Health Canada	—	Marketed in Canada as MITOMYCIN FOR INJECTION USP (DIN 02464691) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 30, 2018	health-canada-dpd
Mitomycin	CA Health Canada	—	Marketed in Canada as MITOMYCIN FOR INJECTION USP (DIN 02237745) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Feb 28, 2020	Jul 15, 1998	health-canada-dpd
Mitomycin	CA Health Canada	—	Marketed in Canada as MITOMYCIN FOR INJECTION USP (DIN 02230729) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Feb 28, 2020	Mar 12, 1998	health-canada-dpd
Mitomycin	CA Health Canada	—	Marketed in Canada as MITOMYCIN FOR INJECTION (DIN 02230450) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Feb 10, 2017	Oct 22, 1997	health-canada-dpd
Mitomycin	CA Health Canada	—	Marketed in Canada as MITOMYCIN FOR INJECTION (DIN 02230451) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 22, 1997	health-canada-dpd
Mitomycin	CA Health Canada	—	Marketed in Canada as MUTAMYCIN INJ 20MG/VIAL (DIN 00587710) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince May 29, 2006	Dec 31, 1984	health-canada-dpd
Mitomycin	CA Health Canada	—	Marketed in Canada as MUTAMYCIN INJ 5MG/VIAL (DIN 00381799) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince May 29, 2006	Dec 31, 1977	health-canada-dpd
Mitomycin	CA Health Canada	—	Marketed in Canada as MITOMYCIN FOR INJECTION (DIN 02557762) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Mitomycin	US FDA	Non-Muscle Invasive Bladder Carcinoma	ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 )	approved	Jun 12, 2025	openfda
Mitomycin	US FDA	—	JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )	approved	Apr 15, 2020	openfda
Mitomycin	US FDA	—	Mitosol ® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. Mitosol ® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. ( 1 )	approved	Feb 7, 2012	openfda
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN INJECTION, USP (DIN 02458403) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 13, 2022	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN INJECTION, USP (DIN 02457423) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 31, 2022	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as TARO-OXALIPLATIN (DIN 02449692) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 18, 2024	Feb 15, 2017	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN INJECTION (DIN 02436167) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	Jan 2, 2016	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN (DIN 02444763) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 17, 2015	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN INJECTION (DIN 02436957) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 17, 2015	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as PMS-OXALIPLATIN (DIN 02437074) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 4, 2025	Dec 16, 2015	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN INJECTION (DIN 02435071) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 16, 2015	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as ACT OXALIPLATIN (DIN 02432617) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 9, 2018	Dec 16, 2015	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as ELOXATIN (DIN 02296276) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 4, 2016	Jun 27, 2008	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as ELOXATIN (DIN 02296268) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Aug 3, 2016	Jun 27, 2008	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as ELOXATIN (DIN 02296284) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Nov 9, 2018	Jul 17, 2007	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN INJECTION (DIN 02536757) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN FOR INJECTION (DIN 02413833) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Oct 25, 2018	—	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as ACT OXALIPLATIN (DIN 02430533) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 24, 2018	—	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN INJECTION (DIN 02431688) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Oct 26, 2018	—	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN INJECTION (DIN 02532131) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as TEVA-OXALIPLATIN INJECTION (DIN 02446227) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 29, 2021	—	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN INJECTION USP (DIN 02433206) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN FOR INJECTION (DIN 02413841) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Oct 25, 2018	—	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as OXALIPLATIN INJECTION (DIN 02454084) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Oxaliplatin	CA Health Canada	—	Marketed in Canada as ACT OXALIPLATIN (DIN 02430525) under ATC L01XA03 OXALIPLATIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 24, 2018	—	health-canada-dpd
Oxaliplatin	US FDA	Malignant Colorectal Neoplasm	treatment of advanced colorectal cancer. Oxaliplatin is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for:	approved	Aug 7, 2009	openfda
Oxaliplatin	US FDA	Malignant Colon Neoplasm	adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. ( 1 )	approved	Aug 7, 2009	openfda
Oxaliplatin	US FDA	Malignant Colon Neoplasm	adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.	approved	Aug 7, 2009	openfda
Oxaliplatin	US FDA	Malignant Colorectal Neoplasm	treatment of advanced colorectal cancer. ( 1 )	approved	Aug 7, 2009	openfda
Pazopanib	CA Health Canada	—	Marketed in Canada as AURO-PAZOPANIB (DIN 02552957) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 14, 2025	health-canada-dpd
Pazopanib	CA Health Canada	—	Marketed in Canada as PMS-PAZOPANIB (DIN 02525666) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 31, 2022	health-canada-dpd
Pazopanib	CA Health Canada	—	Marketed in Canada as VOTRIENT (DIN 02352303) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 13, 2010	health-canada-dpd
Pazopanib	CA Health Canada	—	Marketed in Canada as SANDOZ PAZOPANIB (DIN 02521180) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Oct 26, 2023	—	health-canada-dpd
Pazopanib	CA Health Canada	—	Marketed in Canada as VOTRIENT (DIN 02352311) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 8, 2020	—	health-canada-dpd
Pazopanib	EU EMA	—	Renal-cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft-tissue sarcoma (STS) Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy. Efficacy and safety have only been established in certain STS histological tumour subtypes.	approved	Jun 14, 2010	ema
Pazopanib	US FDA	—	Efficacy supplement 2014-11-18 (see label)	approved	Nov 18, 2014	openfda
Pazopanib	US FDA	—	Efficacy supplement 2012-04-26 (see label)	approved	Apr 26, 2012	openfda
Pazopanib	US FDA	—	Efficacy supplement 2012-01-12 (see label)	approved	Jan 12, 2012	openfda
Pazopanib	US FDA	Soft Tissue Sarcoma	advanced soft tissue sarcoma (STS) who have received prior chemotherapy.	approved	Oct 19, 2009	openfda
Pazopanib	US FDA	Renal Cell Carcinoma	advanced renal cell carcinoma (RCC).	approved	Oct 19, 2009	openfda
Pazopanib	US FDA	Soft Tissue Sarcoma	Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.	approved	Oct 19, 2009	openfda
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