nyuuzyou/wikis huggingface dataset:
Linsitinib (OSI-906)

==Mechanism of action==
An orally bioavailable small molecule inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) with potential antineoplastic activity. Linsitinib selectively inhibits IGF-1R, which may result in the inhibition of tumor cell proliferation and the induction of tumor cell apoptosis.
==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.
===Gastrointestinal stromal tumor===
#SARC 022: Von Mehren M, George S, Heinrich M, Schuetze S, Yap J, Yu J, Abbott A, Litwin S, Crowley J, Belinsky M, Janeway K, Hornick J, Flieder D, Chugh R, Rink L, Van den Abbeele A. Linsitinib (OSI-906) for the Treatment of Adult and Pediatric Wild-Type Gastrointestinal Stromal Tumors, a SARC Phase II Study. Clin Cancer Res. 2020 April 15;26(8):1837-1845. Epub 2019 Dec 2. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT01560260
==Also known as==
*Code name: OSI-906
Category:Drugs
Category:Oral medications
Category:IGFR inhibitors
Category:Gastrointestinal stromal tumor medications (investigational)
Category:Investigational drugs
Lipefilgrastim (Lonquex)

==Mechanism of action==
From NCI: "A long acting glyco-pegylated recombinant form of human granulocyte colony-stimulating factor (G-CSF), with hematopoietic activity. Similar to G-CSF, lipegfilgrastim binds to and activates specific cell surface receptors, and stimulates neutrophil progenitor proliferation and differentiation."
==History of changes in EMA indication==
*2013-07-25: Initial authorization
==Also known as==
*Code name: XM22
*Brand name: Lonquex
Category:Drugs
Category:Pegylated medications
Category:Subcutaneous medications
Category:Granulocyte colony-stimulating factors
Category:Recombinant medications
Category:EMA approved in 2013
Category:Stub
Liposarcoma - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main liposarcoma page for regimens that include active anticancer treatment.
=Advanced or metastatic disease, subsequent lines of therapy=
==Placebo==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Gounder et al. 2022 (SEAL)	Not reported 	Phase 3 (C)	Selinexor 	Shorter PFS (primary endpoint)Median PFS: 2.1 vs 2.8 mo(HR 1.43, 95% CI 1.05-1.92)
No active anticancer treatment.
===References===
#SEAL: Gounder MM, Razak AA, Somaiah N, Chawla S, Martin-Broto J, Grignani G, Schuetze SM, Vincenzi B, Wagner AJ, Chmielowski B, Jones RL, Riedel RF, Stacchiotti S, Loggers ET, Ganjoo KN, Le Cesne A, Italiano A, Garcia Del Muro X, Burgess M, Piperno-Neumann S, Ryan C, Mulcahy MF, Forscher C, Penel N, Okuno S, Elias A, Hartner L, Philip T, Alcindor T, Kasper B, Reichardt P, Lapeire L, Blay JY, Chevreau C, Valverde Morales CM, Schwartz GK, Chen JL, Deshpande H, Davis EJ, Nicholas G, Gröschel S, Hatcher H, Duffaud F, Herráez AC, Beveridge RD, Badalamenti G, Eriksson M, Meyer C, von Mehren M, Van Tine BA, Götze K, Mazzeo F, Yakobson A, Zick A, Lee A, Gonzalez AE, Napolitano A, Dickson MA, Michel D, Meng C, Li L, Liu J, Ben-Shahar O, Van Domelen DR, Walker CJ, Chang H, Landesman Y, Shah JJ, Shacham S, Kauffman MG, Attia S. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Oncol. 2022 Aug 1;40(22):2479-2490. Epub 2022 Apr 8. link to original article link to PMC article EuroPMC NCT02606461
Category:Liposarcoma regimens
Category:Disease-specific pages
Category:Soft tissue sarcomas
Category:Null regimens
Lobaplatin (D-19466)

==General information==
Class/mechanism: Third-generation platinum compound with DNA alkylating activity, producing interstrand DNA crosslinks, which result in apoptosis.NCI Drug Dictionary entry for lobaplatin
Route: 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 or the prescribing information.
==Also known as==
*Code name: D-19466
==References==
Category:Drugs
Category:Intravenous medications
Category:Platinum agents
Category:Alkylating agents
Category:Nasopharyngeal carcinoma medications
Category:NMPA approved in 2005
Loncastuximab tesirine (Zynlonta)

==Mechanism of action==
From the NCI Drug Dictionary: An antibody-drug conjugate (ADC) consisting of an anti-CD19 humanized monoclonal antibody conjugated, via a cleavable linker comprised of valine-alanine and maleimide, to a cytotoxic, cross-linking agent pyrrolobenzodiazepine (PBD) dimer, which targets DNA minor grooves, with potential antineoplastic activity. Upon administration, the monoclonal antibody portion of loncastuximab tesirine targets the cell surface antigen CD19 on various cancer cells. Upon antibody/antigen binding and internalization, the cytotoxic PBD moiety is released. The imine groups of the PBD moiety bind to the N2 positions of guanines on opposite strands of DNA. This induces interstrand cross-links in the minor groove of DNA and inhibits DNA replication, which inhibits the proliferation of CD19-overexpressing tumor cells.
==Diseases in which it is used==
*Diffuse large B-cell lymphoma
*High-grade B-cell lymphoma
*Transformed lymphoma
==History of changes in FDA indication==
*2021-04-23: Granted accelerated approval for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma. (Based on LOTIS-2)
==History of changes in EMA indication==
*2022-12-20: Granted conditional authorization as monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
==Also known as==
*Code name: ADCT-402
*Generic name: loncastuximab tesirine-lpyl
*Brand name: Zynlonta
Category:Drugs
Category:Intravenous medications
Category:Anti-CD19 antibody-drug conjugates
Category:Alkylating agents
Category:Diffuse large B-cell lymphoma medications
Category:High-grade B-cell lymphoma medications
Category:Transformed lymphoma medications
Category:FDA approved in 2021
Category:EMA approved in 2022
Loperamide (Imodium)

From Wikipedia: Loperamide is an opioid-receptor agonist and acts on the μ-opioid receptors in the myenteric plexus of the large intestine. Loperamide works like morphine, decreasing the activity of the myenteric plexus, which decreases the tone of the longitudinal and circular smooth muscles of the intestinal wall. This increases the time material stays in the intestine, allowing more water to be absorbed from the fecal matter. Loperamide also decreases colonic mass movements and suppresses the gastrocolic reflex.
==Also known as==
*Brand name: Imodium
Category:Drugs
Category:Oral medications
Category:Anti-diarrheals
Category:OTC medications
Category:FDA approved in 1976
Category:WHO Essential Pain and Palliative Care Medicine
Lorazepam (Ativan)

=Mechanism of action=
Benzodiazepine with useful anti-emetic properties especially with regards to prevention of anticipatory nausea.
==Also known as==
*Brand name: Ativan
Category:Drugs
Category:Intravenous medications
Category:Oral medications
Category: Emesis prevention
Category:Benzodiazepine
Category:FDA approved in 1977
Lorlatinib (Lorbrena)

==General information==
Class/mechanism, from the NCI Drug Dictionary: An orally available, ATP-competitive inhibitor of the receptor tyrosine kinases, anaplastic lymphoma kinase (ALK) and C-ros oncogene 1 (Ros1), with potential antineoplastic activity. Upon administration, lorlatinib binds to and inhibits both ALK and ROS1 kinases. The kinase inhibition leads to disruption of ALK- and ROS1-mediated signaling and eventually inhibits tumor cell growth in ALK- and ROS1-overexpressing tumor cells. In addition, lorlatinib is able to cross the blood brain barrier.
Route: PO
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 or the prescribing information. 
==Diseases for which it is used==
*ALK+ non-small cell lung cancer
*ROS1+ non-small cell lung cancer
==History of changes in FDA indication==
* 2018-11-02: Granted accelerated approval for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. (Based on B7461001)
** 2021-03-03: Granted regular approval for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. (Converted to regular approval; prior therapy requirement removed; based on CROWN)
==History of changes in EMA indication==
*2019-05-06: Initial conditional approval as Lorviqua
==History of changes in Health Canada indication==
*2019-02-22: Initial notice of compliance with conditions
*2022-05-20: Conditions were met
==History of changes in PMDA indication==
*2018-09-21: Conditional new approval for the treatment of unresectable or recurrent anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with resistance or intolerance to ALK tyrosine kinase inhibitors.
*2021-11-25: New indication for the treatment of unresectable or advanced/recurrent anaplastic lymphoma kinase (ALK) fusion gene-positive non-small cell lung cancer.
==Patient Drug Information==
*Lorlatinib (Lorbrena) Package InsertLorlatinib (Lorbrena) Package Insert
==Also known as==
*Code name: PF-06463922
*Brand name: Lorbrena, Lorviqua
==References==
Category:Drugs
Category:Oral medications
Category:Mutation-specific medications
Category:ALK inhibitors
Category:ROS1 inhibitors
Category:Non-small cell lung cancer medications
Category:FDA approved in 2018
Category:EMA approved in 2019
Category:Health Canada approved in 2019
Category:PMDA approved in 2018
Low-grade glioma - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main low-grade glioma page for regimens that include active anticancer treatment.
=Adjuvant therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Shaw et al. 2012 (RTOG 9802)	1998-2002 	Phase 3 (C)	PCV 	Shorter OS1Median OS: 7.8 vs 13.3 years(HR 1.69)
1Reported efficacy is based on the 2016 update.
====Preceding treatment====
*Definitive RT x 5400 cGy
===References===
# RTOG 9802: Shaw EG, Wang M, Coons SW, Brachman DG, Buckner JC, Stelzer KJ, Barger GR, Brown PD, Gilbert MR, Mehta MP. Randomized trial of radiation therapy plus procarbazine, lomustine, and vincristine chemotherapy for supratentorial adult low-grade glioma: initial results of RTOG 9802. J Clin Oncol. 2012 Sep 1;30(25):3065-70. Epub 2012 Jul 30. link to original article link to PMC article EuroPMC NCT00003375
## Update: Buckner JC, Shaw EG, Pugh SL, Chakravarti A, Gilbert MR, Barger GR, Coons S, Ricci P, Bullard D, Brown PD, Stelzer K, Brachman D, Suh JH, Schultz CJ, Bahary JP, Fisher BJ, Kim H, Murtha AD, Bell EH, Won M, Mehta MP, Curran WJ Jr. Radiation plus procarbazine, CCNU, and vincristine in low-grade glioma. N Engl J Med. 2016 Apr 7;374(14):1344-55. link to original article link to PMC article EuroPMC
=Residual or recurrent disease, first-line therapy=
==Placebo==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Mellinghoff et al. 2023 (INDIGO)	2020-01 to 2022-02 	Phase 3 (C)	Vorasidenib	Shorter PFS (primary endpoint)Median PFS: 11.1 vs 27.7 mo(HR 2.56, 95% CI 1.79-3.70)
No active antineoplastic therapy.
====Eligibility criteria====
*Grade 2 glioma with no previous treatment other than surgery
====Biomarker eligibility criteria====
*IDH-mutant
===References===
#INDIGO: Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry JR, Giglio P, de la Fuente M, Maher EA, Schoenfeld S, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Cloughesy TF. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023 Aug 17;389(7):589-601. Epub 2023 Jun 4. link to original article EuroPMC NCT04164901
Category:Low-grade glioma regimens
Category:Disease-specific pages
Category:Low-grade gliomas
Category:Null regimens
Lumrotatug (CM-313)

==Mechanism of action==
Anti-CD38 monoclonal antibody
==Diseases for which it is used==
*Immune thrombocytopenia
==History of changes in NMPA indication==
*2024: Initial approval for immune thrombocytopenia (unclear details). (Based on 2022-CM313-ITP)
==Also known as==
*Code name: CM-313
Category:Drugs
Category:Intravenous medications
Category:Anti-CD38 antibodies
Category:Immune thrombocytopenia medications
Category:NMPA approved in 2024
Category:Stub
Lurbinectedin (Zepzelca)

==General information==
Class/mechanism: Alkylator, binds to the minor groove of DNA, which distorts the DNA helix toward the major groove. This binding interrupts normal cell function and interferes with the expression of several several transcription factors, DNA binding proteins, and DNA repair mechanisms, which interrupts cell cycle and leads to tumor death.Lurbinectedin (Zepzelca) package insertLurbinectedin (Zepzelca) package insert (locally hosted backup)Zepzelca manufacturer's website
Route: IV
Extravasation: no information to cite, but suspected vesicant due to its similarity to Trabectedin (Yondelis)
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 or the prescribing information.
==Diseases for which it is used==
*Small cell lung cancer
==Patient drug information==
*Lurbinectedin (Zepzelca) package insert
*Lurbinectedin (Zepzelca) patient drug information (UpToDate)Lurbinectedin (Zepzelca) patient drug information (UpToDate)
==History of changes in FDA indication==
*2020-06-15: Accelerated FDA approval for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. (Based on PM1183-B-005-14)
==History of changes in Health Canada indication==
*2021-09-29: Initial notice of compliance with conditions for the treatment of adults with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after platinum-containing therapy.
==Also known as==
*Code name: PM-01183
*Brand name: Zepzelca
==References==
Category:Drugs
Category:Intravenous medications
Category:Vesicant
Category:Alkylating agents
Category:Small cell lung cancer medications
Category:FDA approved in 2020
Category:Health Canada approved in 2021
Luspatercept (Reblozyl)

==Mechanism of action==
From the NCI Drug Dictionary: A soluble, recombinant fusion protein composed of a modified form of the extracellular domain of human activin receptor type IIb (ActRIIb) and linked to the human IgG1 Fc domain, with red blood cell stimulating activity. Upon subcutaneous administration, luspatercept inhibits several ligands in the transforming growth factor (TGF)-beta superfamily. This prevents activation of a variety of TGF-beta superfamily members involved in late stage erythropoiesis and results in an increased differentiation and proliferation of erythroid progenitors. Luspatercept acts at a different, later stage than erythropoietin.
==Diseases for which it is used==
*Beta thalassemia
*Myelodysplastic syndrome
==History of changes in FDA indication==
*2019-11-08: Initial FDA approval for adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. (Based on BELIEVE)
*2020-04-03: Approved for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). (Based on MEDALIST)
==History of changes in EMA indication==
*2020-06-25: Initial authorization as Reblozyl. Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to erythropoietin-based therapy.
*2020-06-25: Initial authorization as Reblozyl. Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who are ineligible for erythropoietin-based therapy.
*2020-06-25: Initial authorization as Reblozyl. Reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta thalassaemia.
*2023-02-27: Extension of indication in beta thalassaemia to include adult patients with non-transfusion dependent beta-thalassaemia (NTDT).
==History of changes in PMDA indication==
*2024-01-18: Newly indicated for the treatment of anemia associated with myelodysplastic syndrome.
==Also known as==
*Code name: ACE-536
*Generic name: luspatercept-aamt
*Brand name: Reblozyl
Category:Drugs
Category:Subcutaneous medications
Category:Recombinant medications
Category:TGF-beta inhibitors
Category:Beta thalassemia medications
Category:Myelodysplastic syndrome medications
Category:FDA approved in 2019
Category:EMA approved in 2020
Category:PMDA approved in 2024
Lusutrombopag (Mulpleta)

==Mechanism of action==
Thrombopoietin receptor agonist
==Diseases for which it is used==
*Thrombocytopenia in liver disease
==History of changes in FDA indication==
* 2018-07-31: Approved for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
==History of changes in PMDA indication==
*2015-09-28: New approval for the improvement of thrombocytopenia in patients with chronic liver disease for whom an elective invasive procedure is planned.
==Also known as==
*Brand name: Mulpleo, Mulpleta
Category:Drugs
Category:Oral medications
Category:Hematopoietic growth factors
Category:Megakaryocyte growth factors
Category:Thrombocytopenia in liver disease medications
Category:FDA approved in 2018
Category:PMDA approved in 2015
Lutetium Lu 177 dotatate (Lutathera)

==Mechanism of action==
From the NCI Drug Dictionary: A radioconjugate consisting of the tyrosine-containing somatostatin analog Tyr3-octreotate (TATE) conjugated with the bifunctional, macrocyclic chelating agent tetra-azacyclododecanetetra-acetic acid (DOTA) and radiolabeled with the beta-emitting radioisotope lutetium Lu 177 with potential antineoplastic activities. Lutetium Lu 177-DOTA-TATE binds to somatostatin receptors (SSTRs), with high affinity to type 2 SSTR, present on the cell membranes of many types of neuroendocrine tumor (NET) cells. Upon binding and internalization, this radioconjugate specifically delivers a cytotoxic dose of beta radiation to SSTR-positive cells. Tyr3-octreotate (TATE) is an octreotide derivative in which phenylalanine at position 3 is substituted by tyrosine and position 8 threoninol is replaced with threonine.
==Diseases for which it is established==
*Neuroendocrine tumor
**Pancreatic NET
==History of changes in FDA indication==
*2018-01-26: Approved for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. (Based on NETTER-1 and ERASMUS)
*2024-04-23: Approved for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. (Based on NETTER-P)
==History of changes in EMA indication==
*2017-09-26: Initial authorization
==History of changes in Health Canada indication==
*2019-01-09: Initial notice of compliance (unclear details)
==History of changes in PMDA indication==
*2021-06-23: Newly indicated for the treatment of somatostatin receptor-positive neuroendocrine tumor.
== Patient Drug Information==
*Lutetium Lu 177 dotatate (Lutathera) Package InsertLutetium Lu 177 dotatate (Lutathera) Package Insert
==Also known as==
*Generic name: lutetium (177Lu) oxodotreotide
*Brand name: Lutathera
==References==
Category:Drugs
Category:Intravenous medications
Category:Protein expression-specific medications
Category:Radioconjugate
Category:Somatostatin analogs
Category:Radiotherapy medications
Category:Neuroendocrine tumor medications
Category:Pancreatic NET medications
Category:EMA approved in 2017
Category:FDA approved in 2018
Category:Health Canada approved in 2019
Category:PMDA approved in 2021