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

ema

Clinical trials

Active trials (1,109)

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 · 5,092 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1,101–1,109 of 1,109 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
NCT04736589	Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway	not yet recruiting	Phase 3	270

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
Alemtuzumab	EU EMA	Chronic Lymphocytic Leukemia	MabCampath is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL) for whom fludarabine combination chemotherapy is not appropriate.	withdrawnsince Aug 8, 2012	Jul 6, 2001	ema
Alemtuzumab	US FDA	—	Efficacy supplement 2018-11-28 (see label)	approved	Nov 28, 2018	openfda
Alemtuzumab	US FDA	—	Efficacy supplement 2014-11-14 (see label)	approved	Nov 14, 2014	openfda
Alemtuzumab	US FDA	—	Efficacy supplement 2007-09-19 (see label)	approved	Sep 19, 2007	openfda
Alemtuzumab	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
Azacitidine	CA Health Canada	—	Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02505177) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 15, 2024	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02529599) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 17, 2023	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02501791) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Jul 31, 2025	Aug 1, 2022	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02507668) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 24, 2022	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as ONUREG (DIN 02510197) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 10, 2021	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as ONUREG (DIN 02510200) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 10, 2021	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02462826) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 25, 2017	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as REDDY-AZACITIDINE (DIN 02463199) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jun 27, 2023	Oct 25, 2017	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as VIDAZA (DIN 02336707) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 4, 2010	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02534029) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02571102) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as PMS-AZACITIDINE FOR INJECTION (DIN 02532085) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 31, 2026	—	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02564998) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02558815) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as AZACITIDINE FOR INJECTION (DIN 02534037) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Azacitidine	CA Health Canada	—	Marketed in Canada as NAT-AZACITIDINE (DIN 02480220) under ATC L01BC07 AZACITIDINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince May 11, 2023	—	health-canada-dpd
Azacitidine	EU EMA	—	Azacitidine Kabi is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation(HSCT) with: Intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the international prognostic scoring system (IPSS), Chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder, Acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, AML with > 30% marrow blasts according to the WHO classification.	approved	Jan 5, 2024	ema
Azacitidine	EU EMA	Acute Myeloid Leukemia	Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).	approved	Jun 17, 2021	ema
Azacitidine	EU EMA	—	Azacitidine Mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29% marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30% blasts and multi lineage dysplasia, according to World Health Organisation (WHO) classification, AML with > 30% marrow blasts according to the WHO classification.	approved	Mar 27, 2020	ema
Azacitidine	EU EMA	—	Azacitidine betapharm is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 % to 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 % to 30 % blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification, AML with > 30 % marrow blasts according to the WHO classification.	approved	Mar 24, 2020	ema
Azacitidine	EU EMA	—	Azacitidine Accord is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: - intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), - chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder, - acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, - AML with >30% marrow blasts according to the WHO classification.	approved	Feb 13, 2020	ema
Azacitidine	EU EMA	—	Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, AML with >30% marrow blasts according to the WHO classification.	withdrawn	Aug 2, 2019	ema
Azacitidine	EU EMA	—	Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:  intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification. Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.accelerated	approved	Dec 17, 2008	ema
Azacitidine	US FDA	—	Efficacy supplement 2026-04-09 (see label)	approved	Apr 9, 2026	openfda
Azacitidine	US FDA	—	Efficacy supplement 2022-05-20 (see label)	approved	May 20, 2022	openfda
Azacitidine	US FDA	Acute Myeloid Leukemia	ONUREG is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy ( 1 ).	approved	Sep 1, 2020	openfda
Azacitidine	US FDA	—	Myelodysplastic Syndromes (MDS) Azacitidine for Injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information.	approved	Apr 29, 2016	openfda
Azacitidine	US FDA	—	Efficacy supplement 2008-08-20 (see label)	approved	Aug 20, 2008	openfda
Azacitidine	US FDA	—	Efficacy supplement 2007-01-26 (see label)	approved	Jan 26, 2007	openfda
Azacitidine	US FDA	Juvenile Myelomonocytic Leukemia	Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML).	approved	May 19, 2004	openfda
Azacitidine	US FDA	—	Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).	approved	May 19, 2004	openfda
Capecitabine	CA Health Canada	—	Marketed in Canada as CAPECITABINE (DIN 02519887) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 16, 2022	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as CAPECITABINE (DIN 02519879) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 15, 2022	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as CAPECITABINE (DIN 02514982) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 22, 2021	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as CAPECITABINE (DIN 02514990) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 22, 2021	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as MINT-CAPECITABINE (DIN 02508028) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 5, 2021	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as TARO-CAPECITABINE (DIN 02457490) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 31, 2017	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as TARO-CAPECITABINE (DIN 02457504) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 31, 2017	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as ACH-CAPECITABINE (DIN 02426757) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 19, 2014	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as ACH-CAPECITABINE (DIN 02426765) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 19, 2014	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as SANDOZ CAPECITABINE (DIN 02421925) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 23, 2014	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as SANDOZ CAPECITABINE (DIN 02421917) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 23, 2014	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as TEVA-CAPECITABINE (DIN 02400022) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Mar 16, 2022	Aug 19, 2013	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as TEVA-CAPECITABINE (DIN 02400030) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Mar 16, 2022	Aug 19, 2013	health-canada-dpd
Capecitabine	CA Health Canada	—	Marketed in Canada as XELODA (DIN 02238454) under ATC L01BC06 CAPECITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Dec 7, 2022	Sep 10, 1998	health-canada-dpd