| Fludarabine | US FDA | Chronic Lymphocytic Leukemia | Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. Benefit in treatment-naïve or non-refractory CLL patients is not established. | approved | Apr 28, 2004 | openfda |
| Gemtuzumab Ozogamicin | EU EMA | Acute Promyelocytic Leukemia | Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL). | approved | Apr 19, 2018 | ema |
| Gemtuzumab Ozogamicin | US FDA | Acute Myeloid Leukemia | treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older | approved | Sep 1, 2017 | openfda |
| Gemtuzumab Ozogamicin | US FDA | Acute Myeloid Leukemia | treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older | approved | Sep 1, 2017 | openfda |
| Gilteritinib | EU EMA | Acute Myeloid Leukemia | Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. | approved | Oct 24, 2019 | ema |
| Gilteritinib | US FDA | Acute Myeloid Leukemia | XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. | approved | Nov 28, 2018 | openfda |
| Glasdegib | EU EMA | Secondary Acute Myeloid Leukemia | Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy. | approved | Jun 26, 2020 | ema |
| Glasdegib | US FDA | Acute Myeloid Leukemia | DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1 ) | approved | Nov 21, 2018 | openfda |
| Glofitamab | EU EMA | Diffuse Large B-Cell Lymphoma | Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy. | approved | Jul 7, 2023 | ema |
| Histamine | EU EMA | Acute Myeloid Leukemia | Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60. | approved | Oct 7, 2008 | ema |
| Ibritumomab Tiuxetan | EU EMA | Follicular Lymphoma | Zevalin is indicated in adults. [90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsedorrefractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL). | withdrawnsince Jan 4, 2024 | Jan 16, 2004 | ema |
| Ibritumomab Tiuxetan | US FDA | B-Cell Non-Hodgkin Lymphoma | relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) | approved | Feb 19, 2002 | openfda |
| Ibrutinib | US FDA | Waldenstrom Macroglobulinemia | . Adult patients with Waldenström’s macroglobulinemia (WM) | approved | Aug 24, 2022 | openfda |
| Ibrutinib | US FDA | Waldenstrom Macroglobulinemia | . Adult patients with Waldenström’s macroglobulinemia (WM) | approved | Feb 16, 2018 | openfda |
| Ibrutinib | US FDA | Waldenstrom Macroglobulinemia | . Adult patients with Waldenström’s macroglobulinemia (WM) | approved | Feb 16, 2018 | openfda |
| Ibrutinib | US FDA | Waldenstrom Macroglobulinemia | . Adult patients with Waldenström’s macroglobulinemia (WM) | approved | Feb 12, 2014 | openfda |
| Ibrutinib | US FDA | Waldenstrom Macroglobulinemia | . Adult patients with Waldenström’s macroglobulinemia (WM) | approved | Nov 13, 2013 | openfda |
| Idarubicin | US FDA | Acute Myeloid Leukemia | IDAMYCIN PFS is indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. IDAMYCIN PFS is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. (1) | approved | Feb 17, 1997 | openfda |
| Idecabtagene Vicleucel | EU EMA | Multiple Myeloma | Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti CD38 antibody and have demonstrated disease progression on the last therapy. | approved | Aug 18, 2021 | ema |
| 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 | 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 | 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 | 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 | 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 | Myelodysplastic/Myeloproliferative Neoplasm | Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. | approved | Apr 18, 2003 | 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 | Apr 18, 2003 | 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 | Apr 18, 2003 | openfda |
| Imatinib | US FDA | Acute Lymphoblastic Leukemia | Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). | approved | Apr 18, 2003 | 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 | Apr 18, 2003 | openfda |
| Imatinib Mesylate | 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 | Apr 18, 2003 | openfda |
| Imatinib Mesylate | 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 | Apr 18, 2003 | openfda |
| Imatinib Mesylate | 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 | Apr 18, 2003 | openfda |
| Imatinib Mesylate | US FDA | Acute Lymphoblastic Leukemia | Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. | approved | Apr 18, 2003 | openfda |
| Imatinib Mesylate | US FDA | Acute Lymphoblastic Leukemia | Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). | approved | Apr 18, 2003 | openfda |
| Inotuzumab Ozogamicin | EU EMA | Acute Lymphoblastic Leukemia | Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult pPatients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). Besponsa is indicated as monotherapy for paediatric patients 1 year and older with CD22-positive B cell precursor ALL: in first relapse after allo-haematopoietic stem cell transplant (HSCT); after any first relapse in patients with Very High Risk (VHR) disease (see section 5.1); after a second or greater relapse; and in those with refractory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options. | approved | Jun 28, 2017 | ema |
| Inotuzumab Ozogamicin | US FDA | Acute Lymphoblastic Leukemia | 1. INDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older . BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. ( 1 ) | approved | Aug 17, 2017 | openfda |
| Isatuximab | EU EMA | Multiple Myeloma | Sarclisa is indicated: In combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. | approved | May 30, 2020 | ema |
| Isatuximab | US FDA | Multiple Myeloma | SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). SARCLISA is a CD38-directed cytolytic antibody indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). ( 1 ) | approved | Mar 2, 2020 | openfda |
| Ivosidenib | US FDA | Myelodysplastic Syndrome | . Relapsed or refractory Myelodysplastic Syndromes (MDS) For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes | approved | Jul 20, 2018 | openfda |
| Ivosidenib | US FDA | Acute Myeloid Leukemia | Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy | approved | Jul 20, 2018 | openfda |
| Ixazomib | EU EMA | Multiple Myeloma | Ninlaro in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. | approved | Nov 21, 2016 | ema |
| Ixazomib | US FDA | Multiple Myeloma | NINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials [see Warnings and Precautions (5.9) and Clinical Studies (14.2 , 14.3) ] . | approved | Nov 20, 2015 | openfda |
| Larotrectinib | EU EMA | Tumor-agnostic | Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.conditional | approved | Sep 19, 2019 | ema |
| Larotrectinib | US FDA | Tumor-agnostic | VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. ( 1 , 2.1 ) | approved | Nov 26, 2018 | openfda |
| Larotrectinib | US FDA | Tumor-agnostic | VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. ( 1 , 2.1 ) | approved | Nov 26, 2018 | openfda |
| Lenalidomide | US FDA | Marginal Zone Lymphoma | . • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product | approved | Dec 27, 2005 | openfda |
| Lenalidomide | US FDA | Myelodysplastic Syndrome | . • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities | approved | Dec 27, 2005 | openfda |
| Lenalidomide | US FDA | Follicular Lymphoma | . • Previously treated follicular lymphoma (FL), in combination with a rituximab product | approved | Dec 27, 2005 | openfda |
| Lenalidomide | US FDA | Chronic Lymphocytic Leukemia | . Limitations of Use: • REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials | approved | Dec 27, 2005 | openfda |
| Lenalidomide | US FDA | Multiple Myeloma | Multiple myeloma (MM), in combination with dexamethasone | approved | Dec 27, 2005 | openfda |