| Olutasidenib | US FDA | Acute Myeloid Leukemia | Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )] . REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. ( 1 ) | approved | Dec 1, 2022 | openfda |
| Pegaspargase | US FDA | Acute Lymphoblastic Leukemia | Acute lymphoblastic leukemia and hypersensitivity to asparaginase | approved | Feb 1, 1994 | openfda |
| Pegaspargase | US FDA | Acute Lymphoblastic Leukemia | First-line acute lymphoblastic leukemia | approved | Feb 1, 1994 | openfda |
| Pembrolizumab | US FDA | Primary Mediastinal Large B-Cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma (PMBCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy. | approved | Sep 4, 2014 | openfda |
| Pembrolizumab | US FDA | Classic Hodgkin Lymphoma | Classical Hodgkin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL. | approved | Sep 4, 2014 | openfda |
| Pembrolizumab | US FDA | Tumor-agnostic | for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. • Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. • Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. • in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. • in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. • for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. • Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 1 • Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. • Ovarian Cancer in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens. • 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 the confirmatory trials.accelerated | approved |
| Pentostatin | US FDA | Hairy Cell Leukemia | NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms. | approved | Oct 11, 1991 | openfda |
| Pirtobrutinib | US FDA | Mantle Cell Lymphoma | Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. | approved | Jan 27, 2023 | openfda |
| Pirtobrutinib | US FDA | Chronic Lymphocytic Leukemia | . 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. Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.accelerated | approved | Jan 27, 2023 | openfda |
| Plerixafor | US FDA | Multiple Myeloma | Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM). Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma. ( 1 ) | approved | Dec 15, 2008 | openfda |
| Polatuzumab Vedotin | US FDA | Diffuse Large B-Cell Lymphoma | in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies. | approved | Jun 10, 2019 | openfda |
| Polatuzumab Vedotin | US FDA | High Grade B-Cell Lymphoma | in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. | approved | Jun 10, 2019 | openfda |
| Pomalidomide | US FDA | Multiple Myeloma | in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy | approved | Feb 8, 2013 | openfda |
| Pralatrexate | US FDA | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on overall response rate [ see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). FOLOTYN is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). 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 | Sep 24, 2009 | openfda |
| Prednisolone | US FDA | Mycosis Fungoides | Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) | approved | Jun 1, 2006 | openfda |
| Procarbazine | US FDA | Hodgkin Lymphoma | Matulane is indicated for use in combination with other anticancer drugs for the treatment of Stage III and IV Hodgkin's disease. Matulane is used as part of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) regimen. | approved | Jul 22, 1969 | openfda |
| Quizartinib | US FDA | Acute Myeloid Leukemia | VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14) ] . VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test. ( 1 ) Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated. ( 1 ) Limitations of Use VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated [see Clinical Studies (14) ] . | approved | Jul 20, 2023 | openfda |
| Repotrectinib | US FDA | Tumor-agnostic | adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. 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 the confirmatory trials.accelerated | approved | Nov 15, 2023 | openfda |
| Revumenib | US FDA | Acute Myeloid Leukemia | REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. ( 1 ) the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. ( 1 ) Relapsed or Refractory Acute Leukemia REVUFORJ is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. REVUFORJ is indicated for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 ( NPM1 ) mutation [see Dosage and Administration (2.1) , Clinical Pharmacology (12.1) , and Clinical Studies (14.1) ] in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. | approved | Nov 15, 2024 | openfda |
| Rituximab | US FDA | Non-Hodgkin Lymphoma | Adult patients with Non-Hodgkin's Lymphoma (NHL) | approved | Nov 26, 1997 | openfda |
| Romidepsin | US FDA | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ). | approved | Nov 5, 2009 | openfda |
| Ropeginterferon Alfa-2b | US FDA | Polycythemia Vera | The treatment of adults with polycythemia vera. | approved | Nov 12, 2021 | openfda |
| Ropeginterferon Alfa-2b | US FDA | Essential Thrombocythemia | The treatment of adults with essential thrombocythemia. | approved | Nov 12, 2021 | openfda |
| Ruxolitinib | US FDA | Polycythemia Vera | polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. | approved | May 1, 2026 | openfda |
| Ruxolitinib | US FDA | Polycythemia Vera | polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. | approved | Nov 16, 2011 | openfda |
| 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 | 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 |
| 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 |
| Tagraxofusp | US FDA | Blastic Plasmacytoid Dendritic Cell Neoplasm | ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older ( 1 ) | approved | Dec 21, 2018 | 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 who have no satisfactory alternative treatment options. | approved | Jan 23, 2020 | 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 |
| 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 |
| Treosulfan | US FDA | Myelodysplastic Syndrome | . Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). | approved | Jan 21, 2025 | openfda |
| Treosulfan | US FDA | Acute Myeloid Leukemia | Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). | approved | Jan 21, 2025 | openfda |
| Venetoclax | US FDA | Acute Myeloid Leukemia | In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. | approved | Apr 11, 2016 | 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 | 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 |