| Selinexor | US FDA | Multiple Myeloma | . In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody | approved | Jul 3, 2019 | openfda |
| Selinexor | US FDA | Multiple Myeloma | In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy | approved | Jul 3, 2019 | openfda |
| Selpercatinib | US FDA | Tumor-agnostic | Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options | approved | Apr 10, 2024 | openfda |
| Selpercatinib | US FDA | Tumor-agnostic | Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options | approved | May 8, 2020 | openfda |
| Tafasitamab | US FDA | Follicular Lymphoma | in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). | approved | Jul 31, 2020 | openfda |
| Tafasitamab | US FDA | Marginal Zone Lymphoma | Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. | approved | Jul 31, 2020 | openfda |
| Tafasitamab | US FDA | Diffuse Large B-Cell Lymphoma | in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). 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).accelerated | approved | Jul 31, 2020 | openfda |
| Talquetamab | US FDA | Multiple Myeloma | TALVEY 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 and description of clinical benefit in a confirmatory trial(s). TALVEY is a bispecific GPRC5D-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 and description of clinical benefit in a confirmatory trial(s). ( 1 )accelerated | approved | Aug 9, 2023 | openfda |
| Tazemetostat | US FDA | Follicular Lymphoma | Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. | approved | Jan 23, 2020 | openfda |
| Tazemetostat | US FDA | Follicular Lymphoma | Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. | approved | Jan 23, 2020 | openfda |
| Teclistamab | US FDA | Multiple Myeloma | TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. TECVAYLI 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: in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent ( 1 ). as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody ( 1 ). | approved | Oct 25, 2022 | openfda |
| Thalidomide | US FDA | Multiple Myeloma | THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). | approved | Jul 16, 1998 | openfda |
| Trametinib | 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 and duration of response. 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.accelerated | approved | Mar 16, 2023 | openfda |
| Trametinib | 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 and duration of response. 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.accelerated | approved | May 29, 2013 | openfda |
| Trastuzumab Deruxtecan | US FDA | Tumor-agnostic | HER2-Positive Locally Advanced or Metastatic Gastric Cancer as monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. • HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options* • * These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 14.3 , 14.5 )accelerated | approved | Dec 20, 2019 | openfda |
| Trastuzumab Deruxtecan | US FDA | Tumor-agnostic | HER2-Positive Locally Advanced or Metastatic Gastric Cancer as monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. • HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options* • * These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 14.3 , 14.5 )accelerated | approved | Dec 20, 2019 | openfda |
| Vinblastine | US FDA | Hodgkin Lymphoma | Generalized Hodgkin’s disease (Stages III and IV, Ann Arbor modification of Rye staging system) | approved | Apr 29, 1987 | openfda |
| Vinblastine | US FDA | Mycosis Fungoides | Mycosis fungoides (advanced stages) | approved | Apr 29, 1987 | openfda |
| Vorasidenib | US FDA | Grade 2 Follicular Lymphoma | VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection [see Dosage and Administration (2.1) , Clinical Pharmacology (12.1) and Clinical Studies (14) ]. VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, as detected by an FDA-approved test, following surgery including biopsy, sub-total resection, or gross total resection. ( 1 ) | approved | Aug 6, 2024 | openfda |
| Vorinostat | US FDA | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. ( 1 ) | approved | Oct 6, 2006 | openfda |
| Zanubrutinib | US FDA | Mantle Cell Lymphoma | Mantle cell lymphoma (MCL) who have received at least one prior therapy. | approved | Jun 10, 2025 | openfda |
| Zanubrutinib | US FDA | Waldenstrom Macroglobulinemia | 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. Waldenström's macroglobulinemia (WM).accelerated | approved | Jun 10, 2025 | openfda |
| Zanubrutinib | US FDA | Marginal Zone Lymphoma | Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. | approved | Jun 10, 2025 | openfda |
| Zanubrutinib | US FDA | Follicular Lymphoma | Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. | approved | Jun 10, 2025 | openfda |
| Zanubrutinib | US FDA | Mantle Cell Lymphoma | Mantle cell lymphoma (MCL) who have received at least one prior therapy. | approved | Jun 10, 2025 | openfda |
| Zanubrutinib | US FDA | Waldenstrom Macroglobulinemia | 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. Waldenström's macroglobulinemia (WM).accelerated | approved | Jun 10, 2025 | openfda |
| Zanubrutinib | US FDA | Marginal Zone Lymphoma | Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. | approved | Jun 10, 2025 | openfda |
| Zanubrutinib | US FDA | Follicular Lymphoma | Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. | approved | Jun 10, 2025 | openfda |
| Zanubrutinib | US FDA | Marginal Zone Lymphoma | Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen. | approved | Nov 14, 2019 | openfda |
| Zanubrutinib | US FDA | Mantle Cell Lymphoma | Mantle cell lymphoma (MCL) who have received at least one prior therapy. | approved | Nov 14, 2019 | openfda |
| Zanubrutinib | US FDA | Waldenstrom Macroglobulinemia | 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. Waldenström's macroglobulinemia (WM).accelerated | approved | Nov 14, 2019 | openfda |
| Zanubrutinib | US FDA | Follicular Lymphoma | Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. | approved | Nov 14, 2019 | openfda |