Biomarker · Gene alteration

IDH1 mutation

IDH1 codon 132 mutations detected by PCR or sequencing (or R132H-specific immunohistochemistry in glioma); used as a predictive marker for IDH1 inhibitors in acute myeloid leukemia and cholangiocarcinoma and as a diagnostic marker in glioma.

CI-BIO-00000047IDH1 graph →NCIt C118389

Also calledIDH1-mutated · IDH1 R132 · R132H · R132C

Derived

Associated cancers (13)

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
Acute Myeloid Leukemia	11	6	3	2	1 / 6 / 1 / 3 / 0
Anaplastic Astrocytoma	2	—	2	—	0 / 2 / 0 / 0 / 0
Cholangiocarcinoma	2	2	—	—	1 / 1 / 0 / 0 / 0
Glioblastoma	2	—	2	—	0 / 2 / 0 / 0 / 0
High-Grade Glioma, NOS

Derived

Drugs with predictive evidence (11)

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
IvosidenibSmall Molecule	6	6	—	A	6 / 0	Acute Myeloid Leukemia, Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma
VorasidenibSmall Molecule	2	2	—	A	6 / 0	Glioma

Curated evidence

Predictive evidence items (18)

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

civicCuratedShowing 1–18 of 18 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
IDH1 R132C6
BPTES	Acute Myeloid Leukemia

Regulatory

Approvals mentioning the linked drugs (260)

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

openfda

Clinical trials

Active trials (332)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 184 recruiting · 50 active phase 3 · 857 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 51–100 of 332 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
NCT03953898	Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation	active not recruiting	Phase 2

Literature

Linked publications (25)

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

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

Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.
· Lancet Oncol · 2020 · PMID 32416072 · validated civic_curation pubmed
Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma.
· N Engl J Med · 2023 · PMID 37272516 · validated civic_curation pubmed
Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML.
· N Engl J Med · 2018 · PMID 29860938 · validated civic_curation pubmed
IDH1 and IDH2 mutations in gliomas.
· N Engl J Med · 2009 · PMID 19228619 · validated civic_curation

IDH1 Mutation4
Ivosidenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	3	accepted	EID7278 I phase 1 trial for patients with IDH1-mutated AML, patients who received ivosidenib (AG-120). The rate of complete remission was 21.6%, the over all response rate was 30.4%. PMID 29860938 · DiNardo et al., 2018 · Open in CIViC	civic
Venetoclax	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID8856 In this case series, 7 elderly patients with secondary AML (sAML) not eligible for intensive chemotherapy and refractory to HMA (including 1 patient with antecedent myeloproliferative neoplasm) were t… (full text at CIViC) PMID 30725494 · Huemer et al., 2019 · Open in CIViC	civic
Ivosidenib	Cholangiocarcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID7447 In a phase1 trial, 73 patients with cholangiocarcinoma harboring IDH1 mutations were treated with mutant IDH1 inhibitor ivosidenib. The response rate was 5%, median progression free survival was 3.8 m… (full text at CIViC) PMID 31300360 · Lowery et al., 2019 · Open in CIViC	civic
Olaparib	Brain GliomaUNRESOLVED	Predictive	D	Supports Sensitivity Response	3	accepted	EID2933 Mutations in isocitrate dehydrogenase 1 and 2, which result in overproduction of 2-hydroxyglutarate (2HG). 2HG is considered to be an oncometabolite, or a metabolite that promotes carcinogenesis, and … (full text at CIViC) PMID 28148839 · Sulkowski et al., 2017 · Open in CIViC	civic

IDH1 Mutation4

Ivosidenib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID7278

I phase 1 trial for patients with IDH1-mutated AML, patients who received ivosidenib (AG-120). The rate of complete remission was 21.6%, the over all response rate was 30.4%.

PMID 29860938 · DiNardo et al., 2018 · Open in CIViC

civic

Venetoclax

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID8856

In this case series, 7 elderly patients with secondary AML (sAML) not eligible for intensive chemotherapy and refractory to HMA (including 1 patient with antecedent myeloproliferative neoplasm) were t… (full text at CIViC)

PMID 30725494 · Huemer et al., 2019 · Open in CIViC

civic

Ivosidenib

Cholangiocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID7447

In a phase1 trial, 73 patients with cholangiocarcinoma harboring IDH1 mutations were treated with mutant IDH1 inhibitor ivosidenib. The response rate was 5%, median progression free survival was 3.8 m… (full text at CIViC)

PMID 31300360 · Lowery et al., 2019 · Open in CIViC

civic

Olaparib

Brain GliomaUNRESOLVED

Predictive

Supports Sensitivity Response

accepted

EID2933

Mutations in isocitrate dehydrogenase 1 and 2, which result in overproduction of 2-hydroxyglutarate (2HG). 2HG is considered to be an oncometabolite, or a metabolite that promotes carcinogenesis, and … (full text at CIViC)

PMID 28148839 · Sulkowski et al., 2017 · Open in CIViC

civic

IDH1 R132C + IDH1 R132H1
Ivosidenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID12903 Popovici-Muller et al. reported preliminary efficacy data from an ongoing phase 1 study of ivosidenib (AG-120) monotherapy in patients with IDH1-mutated malignancies. In patients with relapsed or refr… (full text at CIViC) PMID 29670690 · Popovici-Muller et al., 2018 · Open in CIViC	civic

IDH1 R132C + IDH1 R132H1

Ivosidenib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID12903

Popovici-Muller et al. reported preliminary efficacy data from an ongoing phase 1 study of ivosidenib (AG-120) monotherapy in patients with IDH1-mutated malignancies. In patients with relapsed or refr… (full text at CIViC)

PMID 29670690 · Popovici-Muller et al., 2018 · Open in CIViC

civic

IDH1 R1323
Ivosidenib	Cholangiocarcinoma	Predictive	A	Supports Sensitivity Response	5	accepted	EID10886 The multicenter randomized double-blind phase 3 study included patients with IDH1-mutant cholangiocarcinoma who had progressed on previous therapy. Patients were randomly assigned to Ivosidenib or pla… (full text at CIViC) PMID 32416072 · Abou-Alfa et al., 2020 · Open in CIViC	civic
Bevacizumab + SunitinibSubstitutes	High-Grade Glioma, NOS	Predictive	B	Supports Sensitivity Response	2	accepted	EID2020 In a clinical study of 63 recurrent glioma patients, the combined cohort of patients treated with either bevacizumab or sunitinib showed that those harboring IDH1 codon 132 mutation were associated wi… (full text at CIViC) PMID 22199315 · Lv et al., 2011 · Open in CIViC	civic
Dasatinib	Intrahepatic Cholangiocarcinoma	Predictive	D	Supports Sensitivity Response	4	accepted	EID6439 Through a high-throughput drug screen of a large panel of cancer cell lines, including 17 biliary tract cancers, this work found that IDH mutant (IDHm) ICC cells demonstrate a striking response to the… (full text at CIViC) PMID 27231123 · Saha et al., 2016 · Open in CIViC	civic

IDH1 R1323

Ivosidenib

Cholangiocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID10886

The multicenter randomized double-blind phase 3 study included patients with IDH1-mutant cholangiocarcinoma who had progressed on previous therapy. Patients were randomly assigned to Ivosidenib or pla… (full text at CIViC)

PMID 32416072 · Abou-Alfa et al., 2020 · Open in CIViC

civic

Bevacizumab + SunitinibSubstitutes

High-Grade Glioma, NOS

Predictive

Supports Sensitivity Response

accepted

EID2020

In a clinical study of 63 recurrent glioma patients, the combined cohort of patients treated with either bevacizumab or sunitinib showed that those harboring IDH1 codon 132 mutation were associated wi… (full text at CIViC)

PMID 22199315 · Lv et al., 2011 · Open in CIViC

IDH1 R132H2
AGI-5198	OligodendrogliomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID979 In pre-clinical studies, an IDH1 inhibitor (AG-5198) impaired growth of glioma / anaplastic oligodendroglioma cell lines with IDH1 R132H mutations. A phase I clinical trial of the AG-120 IDH1 inhibit… (full text at CIViC) PMID 23558169 · Rohle et al., 2013 · Open in CIViC	civic
Ivosidenib	Pancreatic Ductal Adenocarcinoma	Predictive	C	Does Not Support Sensitivity Response	2	accepted	EID5987 A 48-year-old female was diagnosed with metastatic pancreatic ductal adenocarcinoma and subsequently started on standard of care chemotherapy, during which her hepatic lesions progressed. Detailed mol… (full text at CIViC) PMID 27466707 · Brody et al., 2018 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Bevacizumab	US FDA	Renal Cell Carcinoma	Metastatic renal cell carcinoma in combination with interferon alfa.	approved	Feb 26, 2004	openfda
Bevacizumab	US FDA	Glioblastoma	Recurrent glioblastoma in adults.	approved	Feb 26, 2004	openfda
Dasatinib	CA Health Canada	—	Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562472) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 31, 2026	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562464) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 31, 2026	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562480) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 31, 2026	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562502) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 31, 2026	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as APO-DASATINIB TABLETS (DIN 02562499) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 31, 2026	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TEVA-DASATINIB (DIN 02478323) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 5, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TEVA-DASATINIB (DIN 02478307) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 5, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TEVA-DASATINIB (DIN 02478358) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 5, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TEVA-DASATINIB (DIN 02478331) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 5, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TEVA-DASATINIB (DIN 02478315) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 5, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TARO-DASATINIB (DIN 02499320) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 4, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TARO-DASATINIB (DIN 02499339) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 4, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TARO-DASATINIB (DIN 02499347) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 4, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TARO-DASATINIB (DIN 02499282) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 4, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TARO-DASATINIB (DIN 02499304) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 4, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as TARO-DASATINIB (DIN 02499312) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 4, 2021	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as APO-DASATINIB (DIN 02481502) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 6, 2020	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as APO-DASATINIB (DIN 02470721) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 6, 2020	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as APO-DASATINIB (DIN 02470705) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 6, 2020	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as APO-DASATINIB (DIN 02470713) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 6, 2020	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as APO-DASATINIB (DIN 02481499) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 6, 2020	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as SPRYCEL (DIN 02360810) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 2, 2011	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as SPRYCEL (DIN 02360829) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Mar 29, 2011	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as SPRYCEL (DIN 02320193) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 4, 2009	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as SPRYCEL (DIN 02293145) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 13, 2007	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as SPRYCEL (DIN 02293129) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 13, 2007	health-canada-dpd
Dasatinib	CA Health Canada	—	Marketed in Canada as SPRYCEL (DIN 02293137) under ATC L01EA02 DASATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 13, 2007	health-canada-dpd
Dasatinib	EU EMA	—	Dasatinib Accord Healthcare is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.  Dasatinib Accord Healthcare is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy.	approved	Jul 26, 2024	ema
Dasatinib	EU EMA	—	Dasatinib Accordpharma is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib. Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Dasatinib Accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ ALL in combination with chemotherapy.	withdrawn	Mar 24, 2022	ema
Dasatinib	EU EMA	Acute Lymphoblastic Leukemia	Dasatinib Accord is indicated for the treatment of adult patients with: • Ph+ acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy. Dasatinib Accord is indicated for the treatment of paediatric patients with: • newly diagnosed Ph+ ALL in combination with chemotherapy.	withdrawn	Mar 24, 2022	ema
Dasatinib	EU EMA	—	Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy. Sprycel is indicated for the treatment of adult patients with: newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase; chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate; Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.	approved	Nov 20, 2006	ema
Dasatinib	US FDA	—	Efficacy supplement 2025-08-01 (see label)	approved	Aug 1, 2025	openfda
Dasatinib	US FDA	—	1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )	approved	Dec 5, 2023	openfda
Dasatinib	US FDA	—	Efficacy supplement 2018-12-21 (see label)	approved	Dec 21, 2018	openfda
Dasatinib	US FDA	—	Efficacy supplement 2017-11-09 (see label)	approved	Nov 9, 2017	openfda
Dasatinib	US FDA	—	Efficacy supplement 2015-08-12 (see label)	approved	Aug 12, 2015	openfda
Dasatinib	US FDA	—	Efficacy supplement 2013-06-17 (see label)	approved	Jun 17, 2013	openfda
Dasatinib	US FDA	—	Efficacy supplement 2010-10-28 (see label)	approved	Oct 28, 2010	openfda
Dasatinib	US FDA	—	Efficacy supplement 2010-10-28 (see label)	approved	Oct 28, 2010	openfda
Dasatinib	US FDA	—	Efficacy supplement 2009-05-21 (see label)	approved	May 21, 2009	openfda
Dasatinib	US FDA	—	Efficacy supplement 2007-11-08 (see label)	approved	Nov 8, 2007	openfda
Dasatinib	US FDA	—	Efficacy supplement 2007-11-08 (see label)	approved	Nov 8, 2007	openfda
Dasatinib	US FDA	—	Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. Dasatinib tablets are a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (1 , 14) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1 , 14) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1 , 14) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. (1 , 14) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (1 , 14)	approved	Jun 28, 2006	openfda
Ivosidenib	EU EMA	—	Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1). Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.	approved	May 4, 2023	ema
Ivosidenib	US FDA	—	Efficacy supplement 2023-10-24 (see label)	approved	Oct 24, 2023	openfda
Ivosidenib	US FDA	—	Efficacy supplement 2022-05-25 (see label)	approved	May 25, 2022	openfda
Ivosidenib	US FDA	—	Efficacy supplement 2021-08-25 (see label)	approved	Aug 25, 2021	openfda
Ivosidenib	US FDA	—	Efficacy supplement 2019-05-02 (see label)	approved	May 2, 2019	openfda