Biomarker · Gene alteration

BCR-ABL1 fusion (Philadelphia chromosome)

The BCR-ABL1 fusion from t(9;22) detected by karyotype, FISH or quantitative RT-PCR of blood or marrow; the defining diagnostic marker of chronic myeloid leukemia, a predictive marker for ABL tyrosine kinase inhibitors, and a molecular-response marker.

CI-BIO-00000052ABL1 graph →BCR graph →NCIt C94600

Also calledBCR-ABL1 · BCR::ABL1 · Philadelphia chromosome · Ph+ · t(9;22) · p210 · p190

Derived

Associated cancers (6)

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
Chronic Myeloid Leukemia, BCR-ABL1 Positive	297	293	—	4	4 / 26 / 146 / 121 / 0
Malignant Neoplasm	22	22	—	—	0 / 0 / 0 / 22 / 0
Acute Lymphoblastic Leukemia	6	6	—	—	0 / 0 / 4 / 2 / 0
B Lymphoblastic Leukemia/Lymphoma with t(9;22)(q34.1;q11.2); BCR-ABL1	4	—	—	4	0 / 4 / 0 / 0 / 0

Derived

Drugs with predictive evidence (8)

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
DasatinibSmall Molecule	106	14	92	A	9 / 47	Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, BCR-ABL1 Positive, Malignant Neoplasm
Imatinib MesylateSmall Molecule	67	—	67	B

Curated evidence

Predictive evidence items (323)

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

civicCuratedShowing 201–250 of 323 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
ABL1 G250E + ABL1 Fusion3
Imatinib

Regulatory

Approvals mentioning the linked drugs (209)

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 (39)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 19 recruiting · 5 active phase 3 · 223 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–39 of 39 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 (32)

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

pubmedPublishedShowing 1–25 of 32 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Novel targeted therapies for Bcr-Abl positive acute leukemias: beyond STI571.
· Oncogene · 2002 · PMID 12476305 · validated civic_curation pubmed
BCR-ABL tyrosine kinase inhibitors in the treatment of Philadelphia chromosome positive chronic myeloid leukemia: a review.
· Leuk Res · 2010 · PMID 20537386 · validated civic_curation pubmed
Characteristics and outcome of chronic myeloid leukemia patients with F317L BCR-ABL kinase domain mutation after therapy with tyrosine kinase inhibitors.
· Blood · 2008 · PMID 18818391 · validated civic_curation pubmed
Resistant mutations in CML and Ph(+)ALL - role of ponatinib.
· Biologics · 2014 · PMID 25349473 · validated

ABL1 Y253F + ABL1 Fusion2
Imatinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID2655 A panel of 18 mutations representing 85% of known mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations were compared with non-mutated BCR-ABL p… (full text at CIViC) PMID 19075254 · Redaelli et al., 2009 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	3	accepted	EID2657 In two cell-based studies, a panel of either 18 or 16 mutations representing 85% of known mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations … (full text at CIViC) PMID 15930265 · O'Hare et al., 2005 · Open in CIViC	civic

ABL1 E255K + ABL1 Fusion4
Imatinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	3	accepted	EID2659 A panel of 18 mutations representing 85% of known mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations were compared with non-mutated BCR-ABL p… (full text at CIViC) PMID 19075254 · Redaelli et al., 2009 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	3	accepted	EID2661 A panel of 16 mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations were compared with non-mutated BCR-ABL protein and evaluated for anti-prolif… (full text at CIViC) PMID 15930265 · O'Hare et al., 2005 · Open in CIViC	civic
Imatinib Mesylate	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID6991 In a study of 39 chronic phase CML patients with BCR-ABL variants, E255K was seen in a single imatinib-resistant patient that was also resistant or intolerant to dasatinib and/or nilotinib treatment. … (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID7039 In a phase II study of 60 imatinib-resistant patients with BCR-ABL mutations, 6 had E255K mutations PMID 17264298 · Guilhot et al., 2007 · Open in CIViC	civic

ABL1 T315I + ABL1 Fusion4
Imatinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	4	accepted	EID2667 A panel of 18 mutations representing 85% of known mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations were compared with non-mutated BCR-ABL p… (full text at CIViC) PMID 19075254 · Redaelli et al., 2009 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	4	accepted	EID2669 A panel of 16 mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations were compared with non-mutated BCR-ABL protein and evaluated for anti-prolif… (full text at CIViC) PMID 15930265 · O'Hare et al., 2005 · Open in CIViC	civic
Imatinib Mesylate	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	3	accepted	EID6990 In a study of 39 chronic phase CML patients with BCR-ABL variants, T315I was seen in 7 imatinib-resistant patients that were also resistant or intolerant to dasatinib and/or nilotinib treatment. Nine … (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID7038 In a phase II study of 60 imatinib-resistant patients with BCR-ABL mutations, 5 had T315I mutations PMID 17264298 · Guilhot et al., 2007 · Open in CIViC	civic

ABL1 F317L + ABL1 Fusion5
Imatinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID2674 A panel of 18 mutations representing 85% of known mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations were compared with non-mutated BCR-ABL p… (full text at CIViC) PMID 19075254 · Redaelli et al., 2009 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID2676 In two cell-based studies, a panel of either 18 or 16 mutations representing 85% of known mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations … (full text at CIViC) PMID 15930265 · O'Hare et al., 2005 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Resistance	2	accepted	EID2680 In two cell-based studies, a panel of either 18 or 16 mutations representing 85% of known mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations … (full text at CIViC) PMID 15930265 · O'Hare et al., 2005 · Open in CIViC	civic
Imatinib Mesylate	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	3	accepted	EID6978 In a study of 39 chronic phase CML patients with BCR-ABL variants, F317L was seen in 8 imatinib resistant patients that were also resistant or intolerant to dasatinib and/or nilotinib treatment. Nine … (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID7045 In a phase II study of 60 imatinib-resistant patients with BCR-ABL mutations, 4 had F317L mutations PMID 17264298 · Guilhot et al., 2007 · Open in CIViC	civic

ABL1 M351T + ABL1 Fusion4
Imatinib	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID2682 A panel of 18 mutations representing 85% of known mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations were compared with non-mutated BCR-ABL p… (full text at CIViC) PMID 19075254 · Redaelli et al., 2009 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID2684 In two cell-based studies, a panel of either 18 or 16 mutations representing 85% of known mutations seen in imatinib CML patents were used to evaluate the effectiveness of drug binding. All mutations … (full text at CIViC) PMID 15930265 · O'Hare et al., 2005 · Open in CIViC	civic
Imatinib Mesylate	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID6989 In a study of 39 chronic phase CML patients with BCR-ABL variants, M351T was seen in a single imatinib-resistant patient that was also resistant or intolerant to dasatinib and/or nilotinib treatment. … (full text at CIViC) PMID 22371878 · Khoury et al., 2012 · Open in CIViC	civic
〃	Chronic Myeloid Leukemia, BCR-ABL1 PositiveALIAS	Predictive	C	Supports Resistance	1	accepted	EID7037 In a phase II study of 60 imatinib-resistant patients with BCR-ABL mutations, 6 had M351T mutations PMID 17264298 · Guilhot et al., 2007 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Ponatinib	CA Health Canada	—	Marketed in Canada as ICLUSIG (DIN 02437333) under ATC L01EA05 PONATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 21, 2015	health-canada-dpd
Ponatinib	EU EMA	—	Iclusig is indicated as monotherapy in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1).  Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.accelerated	approved	Jul 1, 2013	ema
Ponatinib	US FDA	—	Efficacy supplement 2025-10-10 (see label)	approved	Oct 10, 2025	openfda
Ponatinib	US FDA	—	Efficacy supplement 2024-03-19 (see label)	approved	Mar 19, 2024	openfda
Ponatinib	US FDA	—	Efficacy supplement 2022-02-15 (see label)	approved	Feb 15, 2022	openfda
Ponatinib	US FDA	—	Efficacy supplement 2020-12-18 (see label)	approved	Dec 18, 2020	openfda
Ponatinib	US FDA	—	Efficacy supplement 2016-11-28 (see label)	approved	Nov 28, 2016	openfda
Ponatinib	US FDA	—	Efficacy supplement 2016-06-02 (see label)	approved	Jun 2, 2016	openfda
Ponatinib	US FDA	—	ICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors. Accelerated phase (AP) or blast phase (BP) CML for whom no other kinase inhibitors are indicated. T315I-positive CML (chronic phase, accelerated phase, or blast phase). ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL, in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. ( 1 ) Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors. ( 1 ) Accelerated phase (AP) or blast phase (BP) CML for whom no other kinase inhibitors are indicated. ( 1 ) T315I-positive CML (chronic phase, accelerated phase, or blast phase). ( 1 ) Limitations of Use : ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. ( 5.7 ) Limitations of Use : ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML [see Warnings and Precautions (5.7) ] .accelerated	approved	Dec 14, 2012	openfda