| Asciminib | US FDA | — | SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) Previously treated Ph+ CML in CP. ( 1 ) Ph+ CML in CP with the T315I mutation. ( 1 )accelerated | approved | Oct 29, 2021 | openfda |
| Asciminib | US FDA | — | SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) Previously treated Ph+ CML in CP. ( 1 ) Ph+ CML in CP with the T315I mutation. ( 1 )accelerated | approved | Oct 29, 2021 | openfda |
| Axitinib | US FDA | — | Efficacy supplement 2022-09-22 (see label) | approved | Sep 22, 2022 | openfda |
| Axitinib | US FDA | — | Efficacy supplement 2020-06-04 (see label) | approved | Jun 4, 2020 | openfda |
| Axitinib | US FDA | — | in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. | approved | Jan 27, 2012 | openfda |
| Axitinib | US FDA | Renal Cell Carcinoma | in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). | approved | Jan 27, 2012 | openfda |
| Axitinib | US FDA | Renal Cell Carcinoma | as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. | approved | Jan 27, 2012 | openfda |
| Bosutinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) | approved | Sep 26, 2023 | openfda |
| Bosutinib | US FDA | — | Efficacy supplement 2023-09-26 (see label) | approved | Sep 26, 2023 | openfda |
| Bosutinib | US FDA | — | Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ] . BOSULIF is a kinase inhibitor indicated for the treatment of • adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. ( 1 ) | approved | Sep 26, 2023 | openfda |
| Bosutinib | US FDA | — | Efficacy supplement 2021-05-14 (see label) | approved | May 14, 2021 | openfda |
| Bosutinib | US FDA | — | Efficacy supplement 2017-12-19 (see label) | approved | Dec 19, 2017 | openfda |
| Bosutinib | US FDA | — | Efficacy supplement 2017-04-13 (see label) | approved | Apr 13, 2017 | openfda |
| Bosutinib | US FDA | — | Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2) ] . BOSULIF is a kinase inhibitor indicated for the treatment of • adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. ( 1 ) | approved | Sep 4, 2012 | openfda |
| Bosutinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy. ( 1 ) | approved | Sep 4, 2012 | openfda |
| 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 | US FDA | — | Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. • Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). • Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. | approved | Nov 22, 2024 | openfda |
| Imatinib | US FDA | Aggressive Systemic Mastocytosis | Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. | approved | Nov 22, 2024 | openfda |
| Imatinib | US FDA | Myelodysplastic/Myeloproliferative Neoplasm | Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. | approved | Nov 22, 2024 | openfda |
| Imatinib | US FDA | Acute Lymphoblastic Leukemia | Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). | approved | Nov 22, 2024 | openfda |
| Imatinib | US FDA | Acute Lymphoblastic Leukemia | Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. | approved | Nov 22, 2024 | openfda |
| Imatinib | US FDA | Chronic Eosinophilic Leukemia, Not Otherwise Specified | Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. | approved | Nov 22, 2024 | openfda |
| Imatinib | US FDA | Malignant Gastrointestinal Stromal Tumor | Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). | approved | Nov 22, 2024 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2016-08-25 (see label) | approved | Aug 25, 2016 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2015-01-30 (see label) | approved | Jan 30, 2015 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2013-01-25 (see label) | approved | Jan 25, 2013 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2012-01-31 (see label) | approved | Jan 31, 2012 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2011-04-01 (see label) | approved | Apr 1, 2011 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2009-05-27 (see label) | approved | May 27, 2009 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2008-12-19 (see label) | approved | Dec 19, 2008 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2008-09-26 (see label) | approved | Sep 26, 2008 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2007-09-13 (see label) | approved | Sep 13, 2007 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2006-10-19 (see label) | approved | Oct 19, 2006 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2006-10-19 (see label) | approved | Oct 19, 2006 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2006-10-19 (see label) | approved | Oct 19, 2006 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2006-10-19 (see label) | approved | Oct 19, 2006 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2006-10-19 (see label) | approved | Oct 19, 2006 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2006-09-27 (see label) | approved | Sep 27, 2006 | openfda |
| Imatinib | US FDA | — | Efficacy supplement 2005-10-20 (see label) | approved | Oct 20, 2005 | openfda |