KIT mutation

Clinical trials

Active trials (63)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 35 recruiting · 11 active phase 3 · 501 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 63 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
NCT07269470	Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase	recruiting	Phase 2

Literature

Linked publications (44)

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

pubmedPublishedShowing 1–25 of 44 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor.
· J Clin Oncol · 2003 · PMID 14645423 · validated civic_curation pubmed
KIT mutations and dose selection for imatinib in patients with advanced gastrointestinal stromal tumours.
· Eur J Cancer · 2006 · PMID 16624552 · validated civic_curation pubmed
Molecular correlates of imatinib resistance in gastrointestinal stromal tumors.
· J Clin Oncol · 2006 · PMID 16954519 · validated civic_curation pubmed
Prognostic impact of c-KIT mutations in core binding factor leukemias: an Italian retrospective study.
· Blood · 2006 · PMID 16384925 · validated

KIT V560DEL1
Imatinib	Thymus CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	5	accepted	EID486 In a patient with thymic carcinoma, the tumor expressing an activating mutation in exon 11 of KIT (V560del) was sensitive to imatinib. PMID 15201427 · Ströbel et al., 2004 · Open in CIViC	civic

KIT V560DEL1

Thymus CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID486

In a patient with thymic carcinoma, the tumor expressing an activating mutation in exon 11 of KIT (V560del) was sensitive to imatinib.

PMID 15201427 · Ströbel et al., 2004 · Open in CIViC

civic

KIT M541L1
Imatinib	Colon Signet Ring AdenocarcinomaUNRESOLVED	Predictive	E	Supports Sensitivity Response	2	accepted	EID7195 In a study of 44 signet ring cell colorectal cancer cases, 25% were found to carry a KIT M541L mutation. The authors speculate that this relatively high frequency of KIT mutations (actionable in other… (full text at CIViC) PMID 28595259 · Alvi et al., 2017 · Open in CIViC	civic

KIT M541L1

Colon Signet Ring AdenocarcinomaUNRESOLVED

Predictive

Supports Sensitivity Response

accepted

EID7195

In a study of 44 signet ring cell colorectal cancer cases, 25% were found to carry a KIT M541L mutation. The authors speculate that this relatively high frequency of KIT mutations (actionable in other… (full text at CIViC)

PMID 28595259 · Alvi et al., 2017 · Open in CIViC

civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
Imatinib	CA Health Canada	—	Marketed in Canada as IMATINIB (DIN 02521210) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 29, 2024	health-canada-dpd
Imatinib	CA Health Canada	—	Marketed in Canada as IMATINIB (DIN 02521202) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 29, 2024	health-canada-dpd
Imatinib	CA Health Canada	—	Marketed in Canada as JAMP IMATINIB (DIN 02495074) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Jul 31, 2025	Apr 27, 2021	health-canada-dpd
Imatinib	CA Health Canada	—	Marketed in Canada as JAMP IMATINIB (DIN 02495066) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Jul 31, 2025	Apr 27, 2021	health-canada-dpd
Imatinib	CA Health Canada	—	Marketed in Canada as IMATINIB (DIN 02504618) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 7, 2021	health-canada-dpd
Imatinib	CA Health Canada	—	Marketed in Canada as IMATINIB (DIN 02504596) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 7, 2021	health-canada-dpd
Imatinib	CA Health Canada	—	Marketed in Canada as ACH-IMATINIB (DIN 02490994) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 24, 2020	health-canada-dpd

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Acute Lymphoblastic Leukemia

EU EMA

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

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

US FDA

—

Efficacy supplement 2025-08-01 (see label)

approved

Aug 1, 2025

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

US FDA

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Efficacy supplement 2018-12-21 (see label)

approved

Dec 21, 2018

US FDA

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Efficacy supplement 2017-11-09 (see label)

approved

Nov 9, 2017

US FDA

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Efficacy supplement 2015-08-12 (see label)

approved

Aug 12, 2015

US FDA

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Efficacy supplement 2013-06-17 (see label)

approved

Jun 17, 2013

US FDA

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Efficacy supplement 2010-10-28 (see label)

approved

Oct 28, 2010

US FDA

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Efficacy supplement 2010-10-28 (see label)

approved

Oct 28, 2010

US FDA

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Efficacy supplement 2009-05-21 (see label)

approved

May 21, 2009

US FDA

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Efficacy supplement 2007-11-08 (see label)

approved

Nov 8, 2007

US FDA

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Efficacy supplement 2007-11-08 (see label)

approved

Nov 8, 2007

US FDA

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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

CA Health Canada

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Marketed in Canada as IMATINIB (DIN 02521210) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Apr 29, 2024

CA Health Canada

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Marketed in Canada as IMATINIB (DIN 02521202) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Apr 29, 2024

CA Health Canada

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Marketed in Canada as JAMP IMATINIB (DIN 02495074) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Dormantsince Jul 31, 2025

Apr 27, 2021

CA Health Canada

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Marketed in Canada as JAMP IMATINIB (DIN 02495066) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Dormantsince Jul 31, 2025

Apr 27, 2021

CA Health Canada

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Marketed in Canada as IMATINIB (DIN 02504618) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Apr 7, 2021

CA Health Canada

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Marketed in Canada as IMATINIB (DIN 02504596) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Apr 7, 2021

CA Health Canada

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Marketed in Canada as ACH-IMATINIB (DIN 02490994) under ATC L01EA01 IMATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Nov 24, 2020