| Acalabrutinib | US FDA | Mantle Cell Lymphoma | In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). | approved | Aug 3, 2022 | openfda |
| Acalabrutinib | US FDA | Mantle Cell Lymphoma | In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). | approved | Aug 3, 2022 | openfda |
| Acalabrutinib | US FDA | Mantle Cell Lymphoma | In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). | approved | Oct 31, 2017 | openfda |
| Alemtuzumab | US FDA | Chronic Lymphocytic Leukemia | CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 ) | approved | May 7, 2001 | openfda |
| Belantamab Mafodotin | US FDA | Multiple Myeloma | BLENREP is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. BLENREP, a B‑cell maturation antigen (BCMA)‑directed antibody and microtubule inhibitor conjugate, is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. ( 1 ) | approved | Oct 23, 2025 | openfda |
| Belinostat | US FDA | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Beleodaq is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response [ see Clinical Studies ( 14 )]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.( 1 )accelerated | approved | Jul 3, 2014 | openfda |
| Bendamustine | US FDA | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. | approved | Jul 3, 2025 | openfda |
| Bendamustine | US FDA | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | approved | Jul 3, 2025 | openfda |
| Bendamustine | US FDA | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | approved | Dec 15, 2022 | openfda |
| Bendamustine | US FDA | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. | approved | Dec 15, 2022 | openfda |
| Bendamustine | US FDA | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | approved | Dec 7, 2022 | openfda |
| Bendamustine | US FDA | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. | approved | Dec 7, 2022 | openfda |
| Bendamustine | US FDA | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1 ) | approved | Dec 7, 2022 | openfda |
| Bendamustine | US FDA | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. | approved | May 15, 2018 | openfda |
| Bendamustine | US FDA | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | approved | May 15, 2018 | openfda |
| Bendamustine | US FDA | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. | approved | Dec 7, 2015 | openfda |
| Bendamustine | US FDA | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | approved | Dec 7, 2015 | openfda |
| Bendamustine | US FDA | Chronic Lymphocytic Leukemia | Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. | approved | Mar 20, 2008 | openfda |
| Bendamustine | US FDA | Indolent B-Cell Non-Hodgkin Lymphoma | Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. | approved | Mar 20, 2008 | openfda |
| Bexarotene | US FDA | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Targretin (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies. | approved | Jun 28, 2000 | openfda |
| Bexarotene | US FDA | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | TARGRETIN ® (bexarotene) Capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. TARGRETIN (bexarotene) is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. ( 1 ) | approved | Dec 29, 1999 | openfda |
| Blinatumomab | US FDA | Acute Lymphoblastic Leukemia | CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. | approved | Dec 3, 2014 | openfda |
| Blinatumomab | US FDA | Acute Lymphoblastic Leukemia | CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. | approved | Dec 3, 2014 | openfda |
| Blinatumomab | US FDA | Acute Lymphoblastic Leukemia | Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). | approved | Dec 3, 2014 | openfda |
| Bortezomib | US FDA | Multiple Myeloma | treatment of adult patients with multiple myeloma | approved | Aug 26, 2024 | openfda |
| Bortezomib | US FDA | Mantle Cell Lymphoma | treatment of adult patients with mantle cell lymphoma | approved | Aug 26, 2024 | openfda |
| Bortezomib | US FDA | Multiple Myeloma | treatment of adult patients with multiple myeloma | approved | Jul 27, 2022 | openfda |
| Bortezomib | US FDA | Mantle Cell Lymphoma | treatment of adult patients with mantle cell lymphoma | approved | Jul 27, 2022 | openfda |
| Bortezomib | US FDA | Multiple Myeloma | Treatment of adult patients with multiple myeloma. | approved | May 2, 2022 | openfda |
| Bortezomib | US FDA | Mantle Cell Lymphoma | Treatment of adult patients with mantle cell lymphoma. | approved | May 2, 2022 | openfda |
| Bortezomib | US FDA | Multiple Myeloma | treatment of adult patients with multiple myeloma | approved | May 13, 2003 | openfda |
| Bortezomib | US FDA | Mantle Cell Lymphoma | treatment of adult patients with mantle cell lymphoma | approved | May 13, 2003 | openfda |
| Brentuximab Vedotin | US FDA | Systemic Anaplastic Large Cell Lymphoma | . • Adult patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen | approved | Aug 19, 2011 | openfda |
| Brentuximab Vedotin | US FDA | Classic Hodgkin Lymphoma | . • Adult patients with classical Hodgkin lymphoma (cHL) after failure of auto-HSCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates | approved | Aug 19, 2011 | openfda |
| Brentuximab Vedotin | US FDA | Classic Hodgkin Lymphoma | . • Adult patients with classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation | approved | Aug 19, 2011 | openfda |
| Brentuximab Vedotin | US FDA | Classic Hodgkin Lymphoma | . • Pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide | approved | Aug 19, 2011 | openfda |
| Brentuximab Vedotin | US FDA | Classic Hodgkin Lymphoma | Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine | approved | Aug 19, 2011 | openfda |
| Calaspargase Pegol | US FDA | Acute Lymphoblastic Leukemia | ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. | approved | Dec 20, 2018 | openfda |
| Carfilzomib | US FDA | Multiple Myeloma | Relapsed or Refractory Multiple Myeloma Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with: Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. Kyprolis is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. | approved | Jul 20, 2012 | 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 | 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 |
| 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 |
| 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 |