| 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 | 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 | 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 |
| Lenalidomide | US FDA | Mantle Cell Lymphoma | . • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib | approved | Dec 27, 2005 | openfda |
| Lomustine | US FDA | Hodgkin Lymphoma | Hodgkin's Lymphoma Gleostine is indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy. | approved | Aug 4, 1976 | openfda |
| Loncastuximab Tesirine | US FDA | High Grade B-Cell Lymphoma | ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZYNLONTA is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. ( 1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )accelerated | approved | Apr 23, 2021 | openfda |
| Mechlorethamine | US FDA | Mycosis Fungoides | VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy ( 1 ). | approved | Aug 23, 2013 | openfda |
| Melphalan | US FDA | Multiple Myeloma | Multiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. IVRA is an alkylating drug indicated for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. ( 1 ) | approved | Aug 18, 2023 | openfda |
| Melphalan | US FDA | Multiple Myeloma | Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. | approved | Mar 10, 2016 | openfda |
| Melphalan | US FDA | Multiple Myeloma | Evomela is an alkylating drug indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. | approved | Mar 10, 2016 | openfda |
| Melphalan | US FDA | Multiple Myeloma | Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. | approved | Jun 9, 2009 | openfda |
| Mercaptopurine | US FDA | Acute Lymphoblastic Leukemia | MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. | approved | Apr 28, 2014 | openfda |
| Mercaptopurine | US FDA | Acute Lymphoblastic Leukemia | 1 INDICATIONS & USAGE Mercaptopurine tablets is a nucleoside metabolic inhibitor indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. | approved | Sep 11, 1953 | openfda |
| Methotrexate | US FDA | Mycosis Fungoides | Treatment of adults with mycosis fungoides | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Acute Lymphoblastic Leukemia | Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Non-Hodgkin Lymphoma | Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Non-Hodgkin Lymphoma | Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Acute Lymphoblastic Leukemia | Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Mycosis Fungoides | Treatment of adults with mycosis fungoides | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Non-Hodgkin Lymphoma | Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Acute Lymphoblastic Leukemia | Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Mycosis Fungoides | Treatment of adults with mycosis fungoides | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Mycosis Fungoides | Treatment of adults with mycosis fungoides | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Acute Lymphoblastic Leukemia | Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Non-Hodgkin Lymphoma | Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen | approved | Nov 29, 2022 | openfda |
| Methotrexate | US FDA | Acute Lymphoblastic Leukemia | Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen | approved | Apr 25, 2017 | openfda |
| Methotrexate | US FDA | Acute Lymphoblastic Leukemia | Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen | approved | Apr 25, 2017 | openfda |
| Methotrexate | US FDA | Acute Lymphoblastic Leukemia | The following neoplastic diseases for the: o Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. | approved | Aug 10, 1959 | openfda |
| Methotrexate | US FDA | Non-Hodgkin Lymphoma | o Treatment of adult and pediatric patients with non-Hodgkin lymphoma. | approved | Aug 10, 1959 | openfda |
| Methotrexate | US FDA | Meningeal Leukemia | o Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. | approved | Aug 10, 1959 | openfda |
| Midostaurin | US FDA | Acute Myeloid Leukemia | Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. | approved | Apr 28, 2017 | openfda |
| Midostaurin | US FDA | Acute Myeloid Leukemia | Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. | approved | Apr 28, 2017 | openfda |
| Mosunetuzumab | US FDA | Follicular Lymphoma | LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).accelerated | approved | Dec 22, 2022 | openfda |
| Nilotinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. | approved | May 29, 2026 | openfda |
| Nilotinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. | approved | Feb 19, 2025 | openfda |
| Nilotinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. | approved | Nov 7, 2024 | openfda |
| Nilotinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. | approved | Oct 29, 2007 | openfda |
| Nilotinib | US FDA | Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive | Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. | approved | Oct 29, 2007 | openfda |
| Nivolumab | US FDA | Classic Hodgkin Lymphoma | adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: | approved | Dec 22, 2014 | openfda |
| Nivolumab | US FDA | Classic Hodgkin Lymphoma | Classical Hodgkin Lymphoma (cHL) • adult and pediatric (12 years and older) patients with previously untreated, Stage III or IV classical Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine (AVD). | approved | Dec 22, 2014 | openfda |
| Obinutuzumab | US FDA | Follicular Lymphoma | in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. | approved | Nov 1, 2013 | openfda |
| Obinutuzumab | US FDA | Chronic Lymphocytic Leukemia | in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). | approved | Nov 1, 2013 | openfda |
| Obinutuzumab | US FDA | Follicular Lymphoma | in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. | approved | Nov 1, 2013 | openfda |