nyuuzyou/wikis huggingface dataset:
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto)

==General information==
Class/mechanism: Radioligand therapeutic agent. The radionucleotide lutetium-177 is linked to vipivotide tetraxetan, which binds to PSMA (prostate-specific membrane antigen), a transmembrane protein that is expressed in prostate cancer. Binding of lutetium Lu 177 vipivotide tetraxetan to PSMA-positive cells results in delivery of beta-minus radiation, resulting in DNA damage and cell death. Lutetium 177's half-life is 6.647 days.Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) package insert Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) package insert (locally hosted backup)Pluvicto manufacturer's website
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.
==Diseases for which it is established==
*Prostate cancer
==Patient drug information==
*Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) package insert
==History of changes in FDA indication==
*2022-03-23: FDA approved for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. (Based on VISIONPrCA)
==History of changes in EMA indication==
*2022-12-09: Initial authorization in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy.
==Also known as==
*Generic names: Lutetium-177-PSMA-617, Lutetium PSMA
*Brand name: Pluvicto
==References==
Category:Drugs
Category:Intravenous medications
Category:Beta emitters
Category:Radioconjugate
Category:Prostate cancer medications
Category:EMA approved in 2022
Category:FDA approved in 2022
MCARH-109

==Mechanism of action==
From the NCI Drug Dictionary: A preparation of autologous T lymphocytes that have been transduced with a retroviral vector expressing a chimeric antigen receptor (CAR) containing a single chain variable fragment (scFv) specific for the tumor-associated antigen (TAA) human G-protein coupled receptor family C group 5 member D (GPRC5D) and the co-stimulatory domain 4-1BB (CD137), with potential immunostimulating and antineoplastic activities. Upon leukapheresis, isolation, transduction, expansion ex vivo, and reintroduction into the patient, the autologous anti-GPRC5D-CAR-4-1BB-expressing T cells MCARH109 specifically recognize and induce selective toxicity in GPRC5D-expressing tumor cells.
==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.
===Multiple myeloma===
#MSKCC 18-367: Mailankody S, Devlin SM, Landa J, Nath K, Diamonte C, Carstens EJ, Russo D, Auclair R, Fitzgerald L, Cadzin B, Wang X, Sikder D, Senechal B, Bermudez VP, Purdon TJ, Hosszu K, McAvoy DP, Farzana T, Mead E, Wilcox JA, Santomasso BD, Shah GL, Shah UA, Korde N, Lesokhin A, Tan CR, Hultcrantz M, Hassoun H, Roshal M, Sen F, Dogan A, Landgren O, Giralt SA, Park JH, Usmani SZ, Rivière I, Brentjens RJ, Smith EL. GPRC5D-Targeted CAR T Cells for Myeloma. N Engl J Med. 2022 Sep 29;387(13):1196-1206. link to original article link to PMC article EuroPMC NCT04555551
Category:Anti-GPRC5D CAR T-cells
Category:Anti-CD137 cellular therapy
Category:Anti-GPRC5D cellular therapy
Category:Intravenous medications
Category:Multiple myeloma medications (investigational)
Category:Investigational drugs
MOR202

==General information==
Class/mechanism from NCI Drug Dictionary: A fully human monoclonal antibody directed against the cell surface glycoprotein CD-38 with potential antineoplastic activity.
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.
Category:Drugs
Category:Intravenous medications
Category:Anti-CD38 antibodies
Category:Halted drugs
Magrolimab (Hu5F9-G4)

==Mechanism of action==
From the NCI Drug Dictionary: A humanized monoclonal antibody targeting the human cell surface antigen CD47, with potential immunostimulating and antineoplastic activities. Upon administration, anti-CD47 monoclonal antibody Hu5F9-G4 selectively binds to CD47 expressed on tumor cells and blocks the interaction of CD47 with its ligand signal regulatory protein alpha (SIRPa), a protein expressed on phagocytic cells. This prevents CD47/SIRPa-mediated signaling, allows the activation of macrophages, through the induction of pro-phagocytic signaling mediated by calreticulin, which is specifically expressed on the surface of tumor cells, and results in specific tumor cell phagocytosis. In addition, blocking CD47 signaling activates an anti-tumor T-lymphocyte immune response and T-cell mediated cell killing.
==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.
===Diffuse large B-cell lymphoma and Follicular lymphoma===
# 5F9003: Advani R, Flinn I, Popplewell L, Forero A, Bartlett NL, Ghosh N, Kline J, Roschewski M, LaCasce A, Collins GP, Tran T, Lynn J, Chen JY, Volkmer JP, Agoram B, Huang J, Majeti R, Weissman IL, Takimoto CH, Chao MP, Smith SM. CD47 Blockade by Hu5F9-G4 and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med. 2018 Nov 1;379(18):1711-1721. link to original article link to PMC article EuroPMC NCT02953509
==Also known as==
*Code names: Hu5F9-G4, ONO-7913
Category:Drugs
Category:Intravenous medications
Category:Anti-CD47 antibodies
Category:Diffuse large B-cell lymphoma medications (investigational)
Category:Follicular lymphoma medications (investigational)
Category:Halted drugs
Mailing list for HemOnc.org

==Joining the Google Groups mailing list==
HemOnc.org maintains a hybrid mailing list & online group discussion board to encourage back and forth communication between the editors of HemOnc.org and the rest of the user community. There are two ways to join:
#Go to https://groups.google.com/forum/#!forum/hemonc_discuss, log in using your Google account, and click "Apply for membership."
#Email hemonc_discuss@googlegroups.com saying that you would like to be added to the mailing list. Please tell us how you discovered HemOnc.org, and if you are interested in contributing to the website, or do you mainly wish to keep updated about what's going on? This will allow you to participate if you do not wish to use a Google login.
==Benefits==
By joining our list, you will:
*Stay informed about what we're working on at HemOnc.org and be the first to know about noteworthy updates to the site
*Be able to discuss potential improvements and new features to be added to the site. We have active discussions about new ways that we can help 
*Learn more about becoming a contributor and get help with making edits to the site
*Communicate directly with the HemOnc.org community about any general hematology/oncology issues
==Flexible communication==
Communication options are flexible. You can choose to receive: 
*No email: only see messages if you go online to the message board (this requires Google login)
*Abridged email: receive one email per day containing parts of the messages from the last day (and links to the full messages)
*Digest email: up to the last 25 full new messages are grouped in a single email
*All email: every individual email/message is emailed to you as soon as it's submitted
To send a message to the group, email hemonc_discuss@googlegroups.com. Only emails sent from existing members will go through to members of the list--please make sure to use an email address that is registered with the group to send the email. You can choose to either send messages to the whole group (preferred so everyone can participate in the discussion), or only to individual members of the group.
==Privacy==
==Other communication==
As a reminder, you can also stay in touch with us by:
*Liking us on Facebook
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*Checking our "What's New" page to see what edits have been made to the site.
Category:General reference pages
Malignant peritoneal mesothelioma

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Last updated on 2024-07-23:1 regimens on this page
1 variants on this page
 
=Guidelines=
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
==EURACAN/PSOGI==
*2020: Kusamura et al. Peritoneal mesothelioma: PSOGI/EURACAN clinical practice guidelines for diagnosis, treatment and follow-up EuroPMC
==NCCN==
*NCCN Guidelines - Mesothelioma: Peritoneal
**2023: Ettinger et al. Mesothelioma: Peritoneal, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology. EuroPMC
=Advanced or metastatic disease, subsequent lines of therapy=
==Atezolizumab & Bevacizumab==
===Regimen===
Study 	Dates of enrollment	Evidence
Raghav et al. 2021 (MDACC 2016-0861)	2017-2019 	Phase 2
====Immunotherapy====
*Atezolizumab (Tecentriq) 1200 mg IV once on day 1
====Targeted therapy====
*Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycles
===References===
#MDACC 2016-0861: Raghav K, Liu S, Overman MJ, Willett AF, Knafl M, Fu SC, Malpica A, Prasad S, Royal RE, Scally CP, Mansfield PF, Wistuba II, Futreal AP, Maru DM, Solis Soto LM, Parra Cuentas ER, Chen H, Villalobos P, Verma A, Mahvash A, Hwu P, Cortazar P, McKenna E, Yun C, Dervin S, Schulze K, Darbonne WC, Morani AC, Kopetz S, Fournier KF, Woodman SE, Yao JC, Varadhachary GR, Halperin DM. Efficacy, Safety, and Biomarker Analysis of Combined PD-L1 (Atezolizumab) and VEGF (Bevacizumab) Blockade in Advanced Malignant Peritoneal Mesothelioma. Cancer Discov. 2021 Nov;11(11):2738-2747. Epub 2021 Jul 14. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT03074513
Category:Malignant peritoneal mesothelioma regimens
Category:Disease-specific pages
Category:Gastrointestinal cancers
Category:Mesotheliomas
Malignant solid neoplasm, EGFR-mutated

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Last updated on 2024-07-23:1 regimens on this page
1 variants on this page
=All lines of therapy=
==Erlotinib monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence
Hainsworth et al. 2018 (MyPathway)	2014-2016 	Phase 2a, fewer than 20 pts in this arm
====Biomarker eligibility criteria====
*Gene: EGFR 
*Alteration: nonsynonymous exon 18 or exon 21 mutations, or exon 19 deletions
*Acceptable methods of measurement: molecular profiling performed on tissue obtained at the most recent tumor biopsy
*Biomarker exclusions: EGFR exon 20 mutations
====Targeted therapy====
*Erlotinib (Tarceva) 150 mg PO once per day on days 1 to 28
28-day cycles
===References===
# MyPathway: Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study. J Clin Oncol. 2018 Feb 20;36(6):536-542. Epub 2018 Jan 10. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02091141
Category:Malignant solid neoplasm, EGFR-mutated regimens
Category:Biomarker-specific pages
Category:Malignant solid neoplasm
Malignant solid neoplasm, ERBB3-mutated

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Last updated on 2024-07-23:1 regimens on this page
1 variants on this page
=All lines of therapy=
==Neratinib monotherapy==
===Regimen===
Study 	Evidence
Hyman et al. 2018 (SUMMITHER)	Non-randomized basket trial, fewer than 20 pts in this subgroup
Note: the cycle length is not described in the manuscript; the authors have clarified that the cycles are 28 days in length. This trial should not be confused with the one by the same name in multiple myeloma.
====Biomarker eligibility criteria====
*Gene: HER3
*Alteration: various substitutions
*Acceptable methods of measurement: next-generation sequencing assay or RT-PCR, Sanger, pyrosequencing, or mass spectrometry-based sequencing methods
====Prior treatment criteria====
* No prior treatment with HER kinase inhibitors
====Targeted therapy====
*Neratinib (Nerlynx) 240 mg PO once per day on days 1 to 28
====Supportive therapy====
*Loperamide (Imodium) (dose not specified) mandatory during cycle 1
28-day cycles
===References===
# SUMMIT: Hyman DM, Piha-Paul SA, Won H, Rodon J, Saura C, Shapiro GI, Juric D, Quinn DI, Moreno V, Doger B, Mayer IA, Boni V, Calvo E, Loi S, Lockhart AC, Erinjeri JP, Scaltriti M, Ulaner GA, Patel J, Tang J, Beer H, Selcuklu SD, Hanrahan AJ, Bouvier N, Melcer M, Murali R, Schram AM, Smyth LM, Jhaveri K, Li BT, Drilon A, Harding JJ, Iyer G, Taylor BS, Berger MF, Cutler RE Jr, Xu F, Butturini A, Eli LD, Mann G, Farrell C, Lalani AS, Bryce RP, Arteaga CL, Meric-Bernstam F, Baselga J, Solit DB. HER kinase inhibition in patients with HER2- and HER3-mutant cancers. Nature. 2018 Feb 8;554(7691):189-194. Epub 2018 Jan 31. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT01953926
Category:Malignant solid neoplasm, ERBB3-mutated regimens
Category:Biomarker-specific pages
Category:Malignant solid neoplasm
Malignant solid neoplasm, RET-mutated

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Last updated on 2024-07-23:1 regimens on this page
1 variants on this page
 
=Advanced or metastatic disease, all lines of therapy=
==Selpercatinib monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence
Subbiah et al. 2022 (LIBRETTO-001RET)	2017-12-04 to 2021-08-04	Phase 1/2 (RT)
Note: this is the phase 2 recommended dosing.
====Targeted therapy====
*Selpercatinib (Retevmo) 160 mg PO twice per day
Continued indefinitely
===References===
# LIBRETTO-001RET: Subbiah V, Wolf J, Konda B, Kang H, Spira A, Weiss J, Takeda M, Ohe Y, Khan S, Ohashi K, Soldatenkova V, Szymczak S, Sullivan L, Wright J, Drilon A. Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial. Lancet Oncol. 2022 Oct;23(10):1261-1273. Epub 2022 Sep 12. link to original article EuroPMC NCT03157128
Category:Malignant solid neoplasm, RET-mutated regimens
Category:Biomarker-specific pages
Category:Malignant solid neoplasm
Malignant solid neoplasm, SMO-mutated or PTCH-1-mutated (Hedgehog)

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Last updated on 2024-07-23:1 regimens on this page
1 variants on this page
=All lines of therapy=
==Vismodegib monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence
Hainsworth et al. 2018 (MyPathway)	2014-2016 	Phase 2a
====Biomarker eligibility criteria====
*SMO p.W535L or other nonsynonymous mutations, or PTCH-1 loss-of-function mutations
====Targeted therapy====
*Vismodegib (Erivedge) 150 mg PO once per day 
Continued indefinitely
===References===
# MyPathway: Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study. J Clin Oncol. 2018 Feb 20;36(6):536-542. Epub 2018 Jan 10. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02091141
Category:Malignant solid neoplasm, SMO-mutated or PTCH-1-mutated (Hedgehog) regimens
Category:Biomarker-specific pages
Category:Malignant solid neoplasm
Malignant solid neoplasm, TMB-H

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Last updated on 2024-07-23:1 regimens on this page
1 variants on this page
=Advanced or metastatic disease, subsequent lines of therapy=
==Pembrolizumab monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence
Marabelle et al. 2020 (KEYNOTE-158TMB-H)	2016-01-15 to 2019-06-25	Phase 2 (RT)
Note: KEYNOTE-158 was a basket study with multiple arms of different enrollment periods.
====Prior treatment criteria====
*One or more lines of standard therapy
====Biomarker eligibility criteria====
*Tumor mutation burden: at least 10 mutations/megabase (mut/Mb)
*Alteration: expression
*Acceptable methods of measurement: FoundationOneCDx
====Immunotherapy====
*Pembrolizumab (Keytruda) 200 mg IV over 30 minutes once on day 1
21-day cycle for up to 35 cycles (2 years)
===References===
# KEYNOTE-158TMB-H: Marabelle A, Fakih M, Lopez J, Shah M, Shapira-Frommer R, Nakagawa K, Chung HC, Kindler HL, Lopez-Martin JA, Miller WH Jr, Italiano A, Kao S, Piha-Paul SA, Delord JP, McWilliams RR, Fabrizio DA, Aurora-Garg D, Xu L, Jin F, Norwood K, Bang YJ. Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. Lancet Oncol. 2020 Oct;21(10):1353-1365. Epub 2020 Sep 10. link to original article EuroPMC NCT02628067
Category:Malignant solid neoplasm, TMB-H regimens
Category:Biomarker-specific pages
Category:Malignant solid neoplasm
Mannitol

==General information==
Class/mechanism: Osmotic agent; increases circulating plasma volume
Route: IV
Extravasation: unknown
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==
No known antineoplastic properties. Used for maintenance of plasma volume in certain chemotherapy protocols.
Category:Drugs
Category:Intravenous medications
Category:Chemotherapy protective agents
Category:FDA approved in 1965
Mapatumumab (HGS-ETR1)

==Mechanism of action==
Monoclonal antibody directed against the tumour necrosis factor-related apoptosis-inducing ligand receptor 1 (TRAIL-R1)
==Also known as==
*Code name: HGS-ETR1
Category:Drugs
Category:Intravenous medications
Category:Anti-TRAIL-R1 antibodies
Category:Investigational drugs
Margetuximab (Margenza)

==Mechanism of action==
From the NCI Drug Dictionary: A Fc-domain optimized IgG monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER2) with potential immunomodulating and antineoplastic activities. After binding to HER2 on the tumor cell surface, margetuximab may induce an antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells overexpressing HER2. HER2, a tyrosine kinase receptor, is overexpressed by many cancer cell types. Compared to other anti-HER2 monoclonal antibodies, the Fc domain of MGAH22 is optimized with increased binding to the activating Fcgamma receptor IIIA (CD16A), expressed on cells such as natural killer (NK) cells and macrophages, thereby mediating an enhanced ADCC; the Fc domain also shows decreased binding to the inhibitory Fcgamma receptor IIB (CD32B).
==Diseases for which it is used==
*HER2+ breast cancer
==History of changes in FDA indication==
*2020-12-16: Approved in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. (Based on SOPHIA)
==Also known as==
*Code name: MGA-H22
*Brand name: Margenza
Category:Drugs
Category:Intravenous medications
Category:Protein expression-specific medications
Category:Anti-HER2 antibodies
Category:Breast cancer medications
Category:FDA approved in 2020
Marginal zone lymphoma - historical

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? Please go to the main MZL regimen page to find other regimens.
Last updated on 2024-12-02:1 regimens on this page
2 variants on this page
=Relapsed or refractory=
==Copanlisib monotherapy==
===Regimen variant #1, flat dose===
Study 	Dates of enrollment 	Evidence 	Efficacy
Dreyling et al. 2017 (CHRONOS-1)	2012 to not reported	Phase 2 (RT)	ORR: 59% (95% CI, 49-68)
Note: this was the FDA-recommended dose and the dose used for most of the patients enrolled in this trial; however, the 2017 publication only detailed the weight-based dosing (see below). The 2021 subgroup analysis did describe this dosing.
====Targeted therapy====
*Copanlisib (Aliqopa) 60 mg IV over 60 minutes once per day on days 1, 8, 15
28-day cycles
===Regimen variant #2, weight-based===
Study 	Dates of enrollment 	Evidence 	Efficacy
Dreyling et al. 2017 (CHRONOS-1)	2012 to not reported	Phase 2 (RT)	ORR: 59% (95% CI, 49-68)
====Targeted therapy====
*Copanlisib (Aliqopa) 0.8 mg/kg IV over 60 minutes once per day on days 1, 8, 15
28-day cycles
===References===
#CHRONOS-1: Dreyling M, Morschhauser F, Bouabdallah K, Bron D, Cunningham D, Assouline SE, Verhoef G, Linton K, Thieblemont C, Vitolo U, Hiemeyer F, Giurescu M, Garcia-Vargas J, Gorbatchevsky I, Liu L, Koechert K, Peña C, Neves M, Childs BH, Zinzani PL. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017 Sep 1;28(9):2169-2178. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT01660451
##Subgroup analysis: Panayiotidis P, Follows GA, Mollica L, Nagler A, Özcan M, Santoro A, Stevens D, Trevarthen D, Hiemeyer F, Garcia-Vargas J, Childs BH, Zinzani PL, Dreyling M. Efficacy and safety of copanlisib in patients with relapsed or refractory marginal zone lymphoma. Blood Adv. 2021 Feb 9;5(3):823-828. link to original article link to PMC article EuroPMC
Category:Marginal zone lymphoma regimens
Category:Historical regimens
Category:Disease-specific pages
Category:Indolent lymphomas
Category:B-cell lymphomas