nyuuzyou/wikis huggingface dataset:
Tabelecleucel (Ebvallo)

==Mechanism of action==
From the NCI Drug Dictionary: Allogeneic cytotoxic T lymphocytes (CTLs) selective for the tumor-associated antigens (TAAs) expressed by the Epstein-Barr virus (EBV), with potential immunostimulating and antineoplastic activities. Upon administration, and after hematopoietic cell transplants (HCT) or solid organ transplants (SOT), or during certain other immunocompromised states, tabelecleucel targets and binds to EBV-associated antigens expressed on EBV-infected cells. This results in lysis of EBV-infected cells and prevents growth of EBV-associated cancer cells.
==Diseases for which it is used==
*Post-transplant lymphoproliferative disorder
==History of changes in EMA indication==
*2022-12-16: Initial authorization as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.
==Also known as==
*Code name: ATA-129
*Generic name: EBV-CTLs
*Brand name: Ebvallo, Tab-cel
Category:Drugs
Category:Cytotoxic T-cells
Category:Intravenous medications
Category:Post-transplant lymphoproliferative disorder medications
Category:EMA approved in 2022
Tacrolimus (Prograf)

==General information==
Class/mechanism: Immunosuppresive medication, calcineurin-inhibitor, inhibits T-cell activity. Exact mechanism of action unknown, but it may involve tacrolimus binding to the intracellular protein FKBP-12, which results in the formation of a complex of tacrolimus, FKBP-12, calcium, calmodulin, and calcineurin. This complex inhibits calcineurin's phosphatase activity and may prevent NF-AT (nuclear factor of activated T-cells) activity, which is believed to be responsible for transcription of lymphokines such as interleukin-2 and gamma interferon). Tacrolimus's activity may involve inhibiting humoral immunity and cell-mediated reactions such as graft versus host disease, allograft rejection, collagen-induced arthritis, delayed type hypersensitivity, and experimental allergic encephalomyelitis.Tacrolimus (Prograf) package insertTacrolimus (Prograf) package insert (locally hosted backup)Prograf manufacturer's website
Route: PO, IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information.
==Patient drug information==
*Tacrolimus (Prograf) package insert PDF pages 38-42
*Tacrolimus (Prograf) patient drug information (UpToDate)Tacrolimus (Prograf) patient drug information (UpToDate)
==Also known as==
*Code name: FK-506
*Brand names: Advagraf, Prograf, Tacforius
==References==
Category:Drugs
Category:Oral medications
Category:Intravenous medications
Category:Calcineurin inhibitors
Category:FDA approved in 1994
Tafasitamab (Monjuvi)

==Mechanism of action==
Anti-CD19 antibody with an engineered Fc region to enhance Fcγ receptor binding affinity
==Diseases for which it is used==
*Diffuse large B-cell lymphoma
*Transformed lymphoma
==History of changes in FDA indication==
*2020-07-31: Granted accelerated approval in combination with lenalidomide for 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. (Based on L-MIND)
==History of changes in EMA indication==
*2021-08-26: Initial conditional approval as Minjuvi
==History of changes in Health Canada indication==
*2021-08-19: Initial notice of compliance with conditions 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, who are not eligible for autologous stem cell transplant (ASCT)
==Also known as==
*Code names: MOR-208, MOR-00208, XmAb-5574
*Generic name: tafasitamab-cxix
*Brand name: Minjuvi, Monjuvi
Category:Drugs
Category:Intravenous medications
Category:Anti-CD19 antibodies
Category:Diffuse large B-cell lymphoma medications
Category:Transformed lymphoma medications
Category:EMA approved in 2021
Category:FDA approved in 2020
Category:Health Canada approved in 2021
Tagraxofusp (Elzonris)

==Mechanism of action==
From the NCI Drug Dictionary: A recombinant protein consisting of human interleukin 3 (IL3) fused to the first 388 amino acids of diphtheria toxin [DT(388)] (DT388IL3) with potential antineoplastic activity. Upon intravenous administration, the IL3 moiety of the tagraxofusp-erzs binds to IL3 receptors on cells expressing the receptor. Subsequently, the DT(388) toxin moiety, which contains both translocation and catalytic domains, is transported across the cell membrane via endocytosis. Within the cytosol, the catalytic domain of the toxin both catalyzes the ADP-ribosylation of, and inactivates, translation elongation factor 2 (EF-2), which results in the inhibition of translation during protein synthesis.
==Diseases for which it is established==
*Blastic plasmacytoid dendritic cell neoplasm
==History of changes in FDA indication==
*2018-12-21: Initial approval for blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. (Based on STML-401-0114)
==History of changes in EMA indication==
*2021-01-07: Initial authorization as Elzonris
==Also known as==
*Code name: SL-401
*Generic name: tagraxofusp-erzs
*Brand name: Elzonris
Category:Drugs
Category:Intravenous medications
Category:IL-3 fused immunotoxins
Category:Blastic plasmacytoid dendritic cell neoplasm medications
Category:FDA approved in 2018
Category:EMA approved in 2021
Talazoparib (Talzenna)

==Mechanism of action==
PARP inhibitor
*IUPHAR/BPS
==Diseases for which it is used==
*BRCA-mutated breast cancer
*Prostate cancer
==History of changes in FDA indication==
*2018-10-16: Initial approval for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. (Based on EMBRACA)
*2023-06-20: Approved with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). (Based on TALAPRO-2)
==History of changes in EMA indication==
*2019-06-20: Initial authorization as Talzenna. Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. (Based on EMBRACA)
*2023-11-09: CHMP recommends new marketing authorisation - Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
==History of changes in PMDA indication==
*2024-01-18: Newly indicated for the treatment of BRCA mutation-positive, metastatic castration-resistant prostate cancer.
*2024-01-18: Newly indicated for the treatment of unresectable or recurrent BRCA mutation-positive and HER2-negative breast cancer in patients who have previously been treated with chemotherapy.
==Also known as==
*Code name: BMN-673
*Brand name: Talzenna
Category:Drugs
Category:Oral medications
Category:Mutation-specific medications
Category:PARP1 inhibitors
Category:PARP2 inhibitors
Category:Breast cancer medications
Category:Prostate cancer medications
Category:FDA approved in 2018
Category:EMA approved in 2019
Category:PMDA approved in 2024
Category:Pfizer product
Talimogene laherparepvec (Imlygic)

==General information==
Class/mechanism: Genetically modified oncolytic viral therapy. Talimogene laherparepvec (Imlygic) is a live, attenuated Herpes Simplex Virus-1 (HSV-1) that has been genetically modified to express human granulocyte-macrophage colony-stimulating factor (huGM-CSF). The modified virus is able to reproduce inside of tumors. The exact mechanism of action is unknown, but the anti-tumor response may be due to the expression of huGM-CSF. It has been observed to cause tumor lysis and release of tumor-derived antigens.Talimogene laherparepvec (Imlygic) package insert Talimogene laherparepvec (Imlygic) package insert (locally hosted backup)Imlygic manufacturer's websiteLawler SE, Chiocca EA. Oncolytic Virus-Mediated Immunotherapy: A Combinatorial Approach for Cancer Treatment. J Clin Oncol. 2015;33(25):2812-4. link to original article EuroPMC
Route: SC (intralesional injection)
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information.
==Diseases for which it is used==
*Melanoma
==Patient drug information==
*Talimogene laherparepvec (Imlygic) package insert
==History of changes in FDA indication==
*2015-10-27: FDA approved for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. (Based on OPTiM)
==History of changes in EMA indication==
*2015-12-16: Initial authorization
==Also Known As==
*Generic name: T-VEC
*Brand names: Imlygic, OncoVEXGM-CSF
==References==
Category:Drugs
Category:Intralesional medications
Category:Locally delivered therapies
Category:Oncolytic viral therapy
Category:Melanoma medications 
Category:EMA approved in 2015
Category:FDA approved in 2015
Taloporfin (Laserphyrin)

Photosensitizer
==Diseases for which it is used==
*Esophageal cancer
==History of changes in PMDA indication==
*2013-09-20: New additional indication and a new dosage for the treatment of primary malignant brain tumor (only for the case where surgical excision of tumor is performed).
*2015-05-26: New additional indication for the treatment of recurrent esophageal cancer associated with local persistence after chemoradiotherapy or radiotherapy.
==Also known as==
*Brand name: Laserphyrin
Category:Drugs
Category:Intravenous medications
Category:Photosensitizers
Category:Esophageal cancer medications
Category:PMDA approved in 2004
Category:Stub
Talquetamab (Talvey)

==Mechanism of action==
From the NCI Drug Dictionary: A bispecific humanized monoclonal antibody against human CD3, a T-cell surface antigen, and human G-protein coupled receptor family C group 5 member D (GPRC5D), a tumor-associated antigen (TAA), with potential antineoplastic activity. Upon administration, talquetamab binds to both CD3 on T cells and GPRC5D expressed on certain tumor cells. This results in the cross-linking of T-cells and tumor cells, and induces a potent cytotoxic T-lymphocyte (CTL) response against GPRC5D-expressing tumor cells.
==Toxicity management==
*Link to REMS program
==Diseases for which it is established==
*Multiple myeloma
==History of changes in FDA indication==
*2023-08-09: Granted accelerated approval for adults 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. (Based on MonumenTAL-1)
==Also known as==
*Code name: JNJ-64407564
*Generic name: talquetamab-tgvs
*Brand name: Talvey
Category:Drugs
Category:Intravenous medications
Category:Anti-GPRC5D-CD3 bispecific antibodies
Category:Multiple myeloma medications
Category:FDA approved in 2023
Category:REMS program
Tamibarotene (Amnoid)

==Mechanism of action==
From the NCI Drug Dictionary: An orally active, synthetic retinoid, developed to overcome all-trans retinoic acid (ATRA) resistance, with potential antineoplastic activity. As a specific retinoic acid receptor (RAR) alpha/beta agonist, tamibarotene is approximately ten times more potent than ATRA in inducing cell differentiation and apoptosis in HL-60 (human promyelocytic leukemia) cell lines in vitro. Due to a lower affinity for cellular retinoic acid binding protein (CRABP), tamibarotene may show sustained plasma levels compared to ATRA. In addition, this agent may exhibit a lower toxicity profile than ATRA, in part, due to the lack of affinity for the RAR-gamma receptor, the major retinoic acid receptor in the dermal epithelium.
==Diseases for which it is used==
*Acute promyelocytic leukemia
==History of changes in PMDA indication==
*2005-04-11: Initial approval for the treatment of Acute promyelocytic leukemia.
==Also known as==
*Brand names: Amnoid, Amnolake
Category:Drugs
Category:Oral medications
Category:Retinoids
Category:Acute promyelocytic leukemia medications
Category:PMDA approved in 2005
Tarlatamab (Imdelltra)

==Mechanism of action==
From the NCI Drug Dictionary: A bispecific T-cell engager (BiTE) antibody composed of two single-chain variable fragments (scFv), one directed against the tumor-associated antigen (TAA) delta-like protein 3 (DLL3) fused to one that is directed against the CD3 antigen found on T lymphocytes, with potential immunostimulating and antineoplastic activities. Upon administration, tarlatamab binds to both the CD3 antigen on cytotoxic T lymphocytes (CTLs) and the DLL3 antigen found on DLL3-expressing tumor cells. This activates and redirects CTLs to DLL3-expressing tumor cells, which results in the CTL-mediated cell death of DLL3-expressing tumor cells.
==Diseases for which it is used==
*Small cell lung cancer
==History of changes in FDA indication==
*2024-05-16: Granted accelerated approval for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. (Based on DeLLphi-301)
==Also known as==
*Code name: AMG-757
*Brand name: Imdelltra
Category:Drugs
Category:Intravenous medications
Category:Anti-DLL3-CD3 bispecific antibodies
Category:Small cell lung cancer medications
Category:FDA approved in 2024
Tasadenoturev (DNX-2401)

==Mechanism of action==
From the NCI Drug Dictionary: An adenovirus serotype 5 strain, selectively replication competent in cells defective in the Rb/p16 tumor suppressor pathway, with potential oncolytic activity. Oncolytic adenovirus Ad5-Delta 24RGD contains an integrin binding RGD-4C motif, allowing Coxsackie adenovirus receptor-independent infection of tumor cells, which are often deficient for Coxsackie and adenovirus receptors (CARs). Selectively replication competent in cells that are defective in retinoblastoma gene (Rb) or cyclin-dependent kinase inhibitor-2A (p16), active replication of oncolytic adenovirus Ad5-Delta 24RGD in tumor cells may induce oncolysis or cell lysis.
==Preliminary data==
Note: This is not meant to be an exhaustive list of preliminary results. References included in this section include non-randomized studies published in high-profile journals (e.g., NEJM) and experimental arms of phase 3 RCTs. Inclusion here is not an indication of impending regulatory approval, although many of these drugs do end up receiving approval by a regulatory authority.
===High-grade glioma, pediatric===
#D24-DIPG: Gállego Pérez-Larraya J, Garcia-Moure M, Labiano S, Patiño-García A, Dobbs J, Gonzalez-Huarriz M, Zalacain M, Marrodan L, Martinez-Velez N, Puigdelloses M, Laspidea V, Astigarraga I, Lopez-Ibor B, Cruz O, Oscoz Lizarbe M, Hervas-Stubbs S, Alkorta-Aranburu G, Tamayo I, Tavira B, Hernandez-Alcoceba R, Jones C, Dharmadhikari G, Ruiz-Moreno C, Stunnenberg H, Hulleman E, van der Lugt J, Idoate MÁ, Diez-Valle R, Esparragosa Vázquez I, Villalba M, de Andrea C, Núñez-Córdoba JM, Ewald B, Robbins J, Fueyo J, Gomez-Manzano C, Lang FF, Tejada S, Alonso MM. Oncolytic DNX-2401 Virus for Pediatric Diffuse Intrinsic Pontine Glioma. N Engl J Med. 2022 Jun 30;386(26):2471-2481. link to original article EuroPMC NCT03178032
==Also known as==
*Code name: DNX-2401
Category:Oncolytic viral therapy
Category:Intralesional medications
Category:High-grade glioma, pediatric medications (investigational)
Category:Investigational drugs
Tazemetostat (Tazverik)

==Mechanism of action==
From the NCI Drug Dictionary: An orally available, small molecule selective and S-adenosyl methionine (SAM) competitive inhibitor of histone methyl transferase EZH2, with potential antineoplastic activity. Upon oral administration, E7438 selectively inhibits the activity of both wild-type and mutated forms of EZH2. Inhibition of EZH2 specifically prevents the methylation of histone H3 lysine 27 (H3K27). This decrease in histone methylation alters gene expression patterns associated with cancer pathways and results in decreased tumor cell proliferation in EZH2 mutated cancer cells.Tazemetostat (Tazverik) package insert Tazemetostat (Tazverik) package insert (locally hosted backup)
==Diseases for which it is used==
*Epithelioid sarcoma
*Follicular lymphoma
==Patient drug information==
*Tazemetostat (Tazverik) package insert
*Tazemetostat (Tazverik) patient drug information (Chemocare)Tazemetostat (Tazverik) patient drug information (Chemocare)
*Tazemetostat (Tazverik) patient drug information (UpToDate)Tazemetostat (Tazverik) patient drug information (UpToDate)
==History of changes in FDA indication==
===Epithelioid sarcoma===
*2020-01-23: Granted accelerated approval for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. (Based on EZH-202)
===Follicular lymphoma===
*2020-06-17: Granted accelerated approval for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) 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. (Based on E7438-G000-101)
*2020-06-17: Granted accelerated approval for adult patients with R/R FL who have no satisfactory alternative treatment options. (Based on E7438-G000-101)
==History of changes in PMDA indication==
*2021-06-23: Newly indicated for the treatment of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (for use only if refractory or intolerant to standard therapies).
==Also known as==
*Code names: E-7438, EPZ-6438
*Brand name: Tazverik
==References==
Category:Drugs
Category:Mutation-specific medications
Category:Oral medications
Category:EZH2 inhibitors
Category:Epithelioid sarcoma medications
Category:Follicular lymphoma medications
Category:FDA approved in 2020
Category:PMDA approved in 2021
Tbo-filgrastim (Granix)

==General information==
Class/mechanism: Recombinant human granulocyte colony-stimulating factor (G-CSF). Binds to cell surface receptors on hematopoietic cells and stimulates proliferation, differentiation, and some end-cell functional activation.Tbo-filgrastim (Granix) package insert Tbo-filgrastim (Granix) package insert (locally hosted backup)Granix manufacturer's website
Route: SC
Extravasation: no known issues
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information. 
==Patient drug information==
*Tbo-filgrastim (Granix) package insert
*Tbo-filgrastim (Granix) patient drug information (UpToDate)Tbo-filgrastim (Granix) patient drug information (UpToDate)
==History of changes in FDA indication==
*2012-08-29: Initial approval for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
==Also known as==
*Brand names: Granix, Neutroval
==References==
Category:Drugs
Category:Subcutaneous medications
Category:Granulocyte colony-stimulating factors
Category:FDA approved in 2012
Tebentafusp (Kimmtrak)

==Mechanism of action==
Bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target glycoprotein 100-positive cells.
==Diseases for which it is used==
*Uveal melanoma
==History of changes in FDA indication==
*2022-01-25: Approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. (Based on IMCgp100-202)
==History of changes in EMA indication==
*2022-04-01: Initial authorization as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
==Also known as==
*Code name: IMC-gp100
*Generic name: tebentafusp-tebn
*Brand name: Kimmtrak
Category:Drugs
Category:Intravenous medications
Category:Uveal melanoma medications
Category:Immunotherapeutic
Category:EMA approved in 2022
Category:FDA approved in 2022
Teclistamab (Tecvayli)

==General information==
Class/mechanism from the NCI Drug Dictionary: A bispecific humanized monoclonal antibody against human CD3, a T-cell surface antigen, and human B-cell maturation antigen (BCMA; TNFRSF17), a tumor-associated antigen (TAA) expressed on plasma cells, with potential antineoplastic activity. Upon administration, teclistamab binds to both CD3 on T cells and BCMA expressed on malignant plasma cells. This results in the cross-linking of T cells and tumor cells, and induces a potent cytotoxic T-lymphocyte (CTL) response against BCMA-expressing plasma cells.
Route: IV
Extravasation: no information
==Toxicity management==
*Link to REMS program
==Diseases for which it is established==
*Multiple myeloma
==History of changes in FDA indication==
*2022-10-25: Approved for 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. (Based on MajesTEC-1 Phase 1 & MajesTEC-1 Phase 2)
*2024-02-20: Approved for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed or refractory multiple myeloma who have achieved and maintained a complete response or better for a minimum of 6 months. (Based on MajesTEC-1 Phase 1 & MajesTEC-1 Phase 2)
==History of changes in EMA indication==
*2022-08-23: Initial conditional approval as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
==Also known as==
*Code name: JNJ-64007957
*Generic name: teclistamab-cqyv
*Brand name: Tecvayli
==References==
Category:Drugs
Category:Intravenous medications
Category:Anti-BCMA-CD3 bispecific antibodies
Category:Multiple myeloma medications
Category:REMS program
Category:EMA approved in 2022
Category:FDA approved in 2022