| Clofarabine | EU EMA | Acute Lymphoblastic Leukemia | Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis. | withdrawnsince Oct 18, 2023 | Nov 14, 2019 | ema |
| Clofarabine | EU EMA | Acute Lymphoblastic Leukemia | Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis. | approved | May 29, 2006 | ema |
| Crisantaspase | EU EMA | Acute Lymphoblastic Leukemia | Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. | approved | Sep 15, 2023 | ema |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. | approved | Sep 7, 2023 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. • adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. | approved | Aug 26, 2011 | openfda |
| Crizotinib | US FDA | Anaplastic Large Cell Lymphoma | pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. | approved | Aug 26, 2011 | openfda |
| Cyclophosphamide | US FDA | Multiple Myeloma | multiple myeloma | approved | Sep 12, 2023 | openfda |
| Cyclophosphamide | US FDA | Mycosis Fungoides | mycosis fungoides (advanced disease) | approved | Sep 12, 2023 | openfda |
| Cytarabine | EU EMA | Meningeal Lymphoma | Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease. | withdrawn | Jul 11, 2001 | ema |
| Dabrafenib | US FDA | Tumor-agnostic | the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. • TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors. ( 5.2 )accelerated | approved | Mar 16, 2023 | openfda |
| Dabrafenib | US FDA | Tumor-agnostic | the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. • TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors. ( 5.2 )accelerated | approved | May 29, 2013 | openfda |
| Daratumumab | US FDA | Multiple Myeloma | DARZALEX is indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma: in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. ( 1 ) | approved | Nov 16, 2015 | openfda |
| 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 |
| Denosumab | US FDA | Multiple Myeloma | Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. | approved | Oct 29, 2025 | openfda |
| Denosumab | US FDA | Multiple Myeloma | Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. | approved | Aug 29, 2025 | openfda |
| Dexamethasone | EU EMA | Multiple Myeloma | Treatment of multiple myeloma. | approved | Mar 16, 2016 | ema |
| Dexamethasone | US FDA | Multiple Myeloma | HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. ( 1 ) | approved | Oct 3, 2019 | openfda |
| Dostarlimab | US FDA | Tumor-agnostic | as a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. • Mismatch Repair Deficient Recurrent or Advanced Solid Tumors • as a single agent for the treatment of adult patients with dMMR recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. 1 • 1 This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).accelerated | approved | Apr 22, 2021 | openfda |
| Doxorubicin | US FDA | Multiple Myeloma | Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy | approved | Nov 17, 1995 | openfda |
| Elotuzumab | EU EMA | Multiple Myeloma | Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).accelerated | approved | May 11, 2016 | ema |
| Elotuzumab | US FDA | Multiple Myeloma | combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (1) | approved | Nov 30, 2015 | openfda |
| Elotuzumab | US FDA | Multiple Myeloma | EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. | approved | Nov 30, 2015 | openfda |
| Elotuzumab | US FDA | Multiple Myeloma | EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in | approved | Nov 30, 2015 | openfda |
| Elotuzumab | US FDA | Multiple Myeloma | combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1) | approved | Nov 30, 2015 | openfda |
| Elranatamab | EU EMA | Multiple Myeloma | Elrexfio is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.conditional | approved | Dec 7, 2023 | ema |
| Elranatamab | US FDA | Multiple Myeloma | ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T‑cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 )accelerated | approved | Aug 14, 2023 | openfda |
| Entrectinib | EU EMA | Tumor-agnosticLung Non-Small Cell Carcinoma | Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing 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 not received a prior NTRK inhibitor who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.conditional | approved | Jul 31, 2020 | ema |
| Entrectinib | US FDA | Tumor-agnostic | Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.accelerated | approved | Oct 20, 2023 | openfda |
| Entrectinib | US FDA | Tumor-agnostic | Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.accelerated | approved | Aug 15, 2019 | openfda |
| Epcoritamab | US FDA | Follicular Lymphoma | This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).accelerated | approved | May 19, 2023 | openfda |
| 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 |
| 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 |
| 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 |
| 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 | 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 | 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 | 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 | Acute Lymphoblastic Leukemia | Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). | 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 |
| 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 |