| Thalidomide | EU EMA | Multiple Myeloma | Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ? 65 years or ineligible for high dose chemotherapy. Thalidomide Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4). | approved | Sep 19, 2022 | ema |
| Thalidomide | EU EMA | Multiple Myeloma | Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4). | approved | Apr 16, 2008 | ema |
| 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 | Mycosis Fungoides | Mycosis fungoides (advanced stages) | approved | Apr 29, 1987 | 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 |
| Vorasidenib | EU EMA | Grade 2 Follicular Lymphoma | Voranigo as monotherapy is indicated for the treatment of predominantly non‑enhancing Grade 2 astrocytoma or oligodendroglioma with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy (see section 5.1). | approved | Sep 17, 2025 | ema |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 |