nyuuzyou/wikis huggingface dataset:
Phytonadione (Vitamin K)

==General information==
Class/mechanism: Vitamin K, which is needed for the production of several vitamin K-dependent clotting factors, such as factor II (prothrombin), factor VII (proconvertin), factor IX (plasma thromboplastin component), factor X (Stuart factor), protein C, and protein S.Phytonadione (Vitamin K) package insertPhytonadione (Vitamin K) package insert (locally hosted backup)Mephyton manufacturer's website
Route: IV, SC, PO
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==
*Phytonadione (Vitamin K) patient drug information (UpToDate)Phytonadione (Vitamin K) patient drug information (UpToDate)
==Also known as==
*Generic name: vitamin K
*Brand names: AquaMephyton, Konakion
==References==
Category:Drugs
Category:Intravenous medications
Category:Oral medications
Category:Subcutaneous medications
Category:Hematology medications
Pictilisib (GDC-0941)

==Mechanism of action==
From the NCI Drug Dictionary: The orally bioavailable bismesylate salt of a potent small-molecule thieno[3,2-d]pyrimidine inhibitor of the class I phosphatidylinositol 3 kinase (PI3K) isoforms p100alpha and p100delta with potential antineoplastic activity. PI3K inhibitor GDC-0941 selectively binds to PI3K isoforms in an ATP-competitive manner, inhibiting the production of the secondary messenger phosphatidylinositol-3,4,5-trisphosphate (PIP3) and activation of the PI3K/Akt signaling pathway.
==Also known as==
*Code name: GDC-0941
Category:Drugs
Category:Oral medications
Category:PI3K alpha inhibitors
Category:PI3K delta inhibitors
Category:Investigational drugs
Pidilizumab (CT-011)

==Mechanism of action==
From NCI Drug Dictionary: A humanized monoclonal antibody directed against human PD-1 (programmed cell death 1; PDCD1), with immunomodulating and antitumor activities. Pidilizumab blocks interaction between the receptor PD-1 with its ligands, PD-1 ligand 1 (PD-1L1) and PD-1 ligand 2 (PD-1L2), resulting in the attenuation of apoptotic processes in lymphocytes, primarily effector/memory T cells, and the augmentation of the anti-tumor activities of NK cells.
==Preliminary data==
===Diffuse large B-cell lymphoma===
# CT-2007-01: Armand P, Nagler A, Weller EA, Devine SM, Avigan DE, Chen YB, Kaminski MS, Kent Holland H, Winter JN, Mason JR, Fay JW, Rizzieri DA, Hosing CM, Ball ED, Uberti JP, Lazarus HM, Mapara MY, Gregory SA, Timmerman JM, Andorsky D, Or R, Waller EK, Rotem-Yehudar R, Gordon LI. Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: Results of an international phase II trial. J Clin Oncol. 2013 Nov 20;31(33):4199-206. Epub 2013 Oct 14. link to original article link to PMC article EuroPMC NCT00532259
===Follicular lymphoma===
# MDACC 2009-0163: Westin JR, Chu F, Zhang M, Fayad LE, Kwak LW, Fowler N, Romaguera J, Hagemeister F, Fanale M, Samaniego F, Feng L, Baladandayuthapani V, Wang Z, Ma W, Gao Y, Wallace M, Vence LM, Radvanyi L, Muzzafar T, Rotem-Yehudar R, Davis RE, Neelapu SS. Safety and activity of PD1 blockade by pidilizumab in combination with rituximab in patients with relapsed follicular lymphoma: a single group, open-label, phase 2 trial. Lancet Oncol. 2014 Jan;15(1):69-77. Epub 2013 Dec 11. link to original article link to PMC article EuroPMC NCT00904722
==Also known as==
*Code name: CT-011, MDV9300
Category:Drugs
Category:Intravenous medications
Category:Anti-PD-1 antibodies
Category:Diffuse large B-cell lymphoma medications (investigational)
Category:Follicular lymphoma medications (investigational)
Category:Investigational drugs
Pimitespib (Jeselhy)

==Mechanism of action==
From the NCI Drug Dictionary: A specific inhibitor of heat shock protein 90 (Hsp90) subtypes alpha and beta, with potential antineoplastic and chemo/radiosensitizing activities. Upon oral administration, Hsp90alpha/beta inhibitor TAS-116 specifically binds to and inhibits the activity of Hsp90 alpha and beta; this results in the proteasomal degradation of oncogenic client proteins, which inhibits client protein dependent-signaling, induces apoptosis, and inhibits the proliferation of cells overexpressing HSP90alpha/beta.
==Diseases for which it is used==
*Gastrointestinal stromal tumor
==History of changes in PMDA indication==
*2022-06-20: A drug with a new active ingredient indicated for the treatment of gastrointestinal stromal tumor that has progressed after cancer chemotherapy.
==Also known as==
*Code name: TAS-116
*Brand name: Jeselhy
Category:Drugs
Category:Oral medications
Category:Hsp90 inhibitors
Category:Gastrointestinal stromal tumor medications
Category:PMDA approved in 2022
Pipobroman (Vercyte)

==Mechanism of action==
Likely to be an alkylating agent
==Diseases for which it is used==
*Polycythemia vera
==Also known as==
*Brand names: Vercite, Vercyte
Category:Drugs
Category:Oral medications
Category:Alkylating agents
Category:Polycythemia vera medications
Category:FDA approved in 1966
Category:Stub
Pirarubicin (THP)

Approved for use in a number of countries; not the US.
==Diseases for which it is used==
*Diffuse large B-cell lymphoma
*Upper tract urothelial carcinoma
==Also known as==
*Code name: 1609-RB
*Generic name: theprubicin, THP-doxorubicin
*Brand names: Pinorubicin, Pinorubin, Therarubicin
Category:Drugs
Category:Intravenous medications
Category:Intravesical medications
Category:Anthracyclines
Category:Diffuse large B-cell lymphoma medications
Category:Upper tract urothelial carcinoma medications
Pirtobrutinib (Jaypirca)

==Mechanism of action==
From the NCI Drug Dictionary: An orally available, selective, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with potential antineoplastic activity. Upon oral administration, BTK inhibitor LOXO-305 selectively and reversibly binds to BTK. This prevents both the activation of the B-cell antigen receptor (BCR) signaling pathway and BTK-mediated activation of downstream survival pathways, thereby inhibiting the growth of malignant B cells that overexpress BTK. Reversible binding of LOXO-305 may preserve antitumor activity in the presence of certain acquired resistance mutations, including C481 mutated BTK, and limit toxicity associated with inhibition of other non-BTK kinases. 
==Diseases for which it is used==
*Chronic lymphocytic leukemia
*Mantle cell lymphoma
==Mechanisms of resistance==
#Wang E, Mi X, Thompson MC, Montoya S, Notti RQ, Afaghani J, Durham BH, Penson A, Witkowski MT, Lu SX, Bourcier J, Hogg SJ, Erickson C, Cui D, Cho H, Singer M, Totiger TM, Chaudhry S, Geyer M, Alencar A, Linley AJ, Palomba ML, Coombs CC, Park JH, Zelenetz A, Roeker L, Rosendahl M, Tsai DE, Ebata K, Brandhuber B, Hyman DM, Aifantis I, Mato A, Taylor J, Abdel-Wahab O. Mechanisms of Resistance to Noncovalent Bruton's Tyrosine Kinase Inhibitors. N Engl J Med. 2022 Feb 24;386(8):735-743. link to original article link to PMC article EuroPMC
==History of changes in FDA indication==
*2023-01-27: Granted accelerated approval for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. (Based on BRUINMCL)
*2023-12-01: Granted accelerated approval for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. (Based on BRUINCLL)
==History of changes in EMA indication==
*2023-04-26: CHMP recommends conditional authorization as Jaypirca. Jaypirca as monotherapy would be indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.
==Also known as==
*Code name: LOXO-305
*Brand name: Jaypirca
Category:Drugs
Category:Oral medications
Category:BTK inhibitors
Category:Chronic lymphocytic leukemia medications
Category:Mantle cell lymphoma medications
Category:FDA approved in 2023
Pixantrone (Pixuvri)

==Mechanism of action==
From the NCI Drug Dictionary: The dimaleate salt of a synthetic, noncardiotoxic aza-anthracenedione analog with potential antineoplastic activity. Pixantrone intercalates into DNA and induces topoisomerase II-mediated DNA strand crosslinks, resulting in inhibition of DNA replication and tumor cell cytotoxicity. 
Route: IV
==Diseases for which it is used==
*Diffuse large B-cell lymphoma
==History of changes in EMA indication==
*2012-05-10: Initial authorization as Pixuvri
*Uncertain date: Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The benefit of pixantrone treatment has not been established in patients when used as fifth-line or greater chemotherapy in patients who are refractory to last therapy.
==Also known as==
*Code name: BBR-2778
*Generic name: pixantrone dimaleate
*Brand name: Pixuvri
Category:Drugs
Category:Intravenous medications
Category:Topoisomerase II inhibitors
Category:Diffuse large B-cell lymphoma medications
Category:EMA approved in 2012
Plerixafor (Mozobil)

==General information==
Class/mechanism: Mobilizes hematopoetic stem cells by inhibiting the CXCR4 chemokine receptor and blocking its cognate ligand, stromal cell-derived factor-1α (SDF-1α). One function of CXCR4 is to anchor stem cells to the marrow matrix via SDF-1α or other adhesion molecules.Plerixafor (Mozobil) package insertPlerixafor (Mozobil) package insert (locally hosted backup)
Route: SC
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==
*WHIM syndrome
==Patient drug information==
*Plerixafor (Mozobil) patient drug information (UpToDate)Plerixafor (Mozobil) patient drug information (UpToDate)
==History of changes in EMA indication==
*2009-07-30: Initial authorization
==History of changes in PMDA indications==
*2016-12-19: Initial approval for the enhancement of mobilization of hematopoietic stem cells to the peripheral blood for autologous peripheral blood stem cell transplantation.
==Also known as==
*Code name: AMD-3100
*Brand name: Mozobil
==References==
Category:Drugs
Category:Subcutaneous medications
Category:CXCR4 inhibitors
Category:Stem cell mobilization medications
Category:WHIM syndrome medications
Category:FDA approved in 2008
Category:EMA approved in 2009
Category:PMDA approved in 2016
Plicamycin (Mithracin)

==General information==
Class/mechanism: Antibiotic oncologic, intercalates DNA base pairs, and inhibits DNA and RNA synthesis. Has been used for hypercalcemia; lowers serum calcium levels independent of cytotoxic activity by blocking parathyroid hormone action on osteoclasts.Plicamycin (Mithracin) package insertPlicamycin (Mithracin) package insert (locally hosted backup)
Route: IV
Extravasation: irritant/vesicant
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==
*Plicamycin (Mithracin) patient drug information (UpToDate)Plicamycin (Mithracin) patient drug information (UpToDate)
==Diseases for which it was used==
*Chronic myeloid leukemia
*Testicular cancer
==History of changes in FDA indication==
*1970: Original approval for an unclear indication. (No supporting studies are cited)
==Also known as==
*Generic name: mithramycin
*Brand name: Mithracin
==References==
Category:Drugs
Category:Intravenous medications
Category:Irritant
Category:Vesicant
Category:Human DNA synthesis inhibitors
Category:Chronic myeloid leukemia medications (historic)
Category:Testicular cancer medications (historic)
Category:FDA approved in 1970
Category:Discontinued drugs
Plinabulin (NPI-2358)

==Mechanism of action==
From the NCI Drug Dictionary: An orally active diketopiperazine derivative with potential antineoplastic activity. Plinabulin selectively binds to the colchicine-binding site of tubulin, thereby interrupting equilibrium of microtubule dynamics; mitotic spindle assembly is disrupted, resulting in cell cycle arrest at the M phase and blockage of cell division in tumor cells. In addition, this agent induces tubulin depolymerization in vascular endothelial cells, resulting in the disruption of tumor blood vessel architecture and a selective collapse of tumor vasculature.
==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.
===Non-small cell lung cancer===
#DUBLIN-3: Han B, Feinstein T, Shi Y, Chen G, Yao Y, Hu C, Shi J, Feng J, Wu H, Cheng Y, Guo QS, Jie Z, Ye F, Zhang Y, Liu Z, Mao W, Zhang L, Lu J, Zhao J, Bazhenova L, Ruiz J, Kloecker GH, Sujith KR, Oliff IA, Wong M, Liu B, Wu Y, Huang L, Sun Y; DUBLIN-3 study group. Plinabulin plus docetaxel versus docetaxel in patients with non-small-cell lung cancer after disease progression on platinum-based regimen (DUBLIN-3): a phase 3, international, multicentre, single-blind, parallel group, randomised controlled trial. Lancet Respir Med. 2024 Oct;12(10):775-786. Epub 2024 Sep 9. link to original article EuroPMC NCT02504489
==Also known as==
*Code name: NPI-2358
Category:Drugs
Category:Oral medications
Category:Diketopiperazine
Category:Non-small cell lung cancer medications (investigational)
Category:Investigational drugs
Polatuzumab vedotin (Polivy)

==General information==
Class/mechanism from the NCI Drug Dictionary: An antibody-drug conjugate (ADC) composed of a monoclonal antibody directed against B-cell antigen receptor complex-associated protein beta chain (CD79B) conjugated, via a protease-cleavable peptide linker, to monomethyl auristatin E (MMAE), an auristatin derivative and a potent microtubule inhibitor, with potential antineoplastic activity. Upon administration, polatuzumab vedotin selectively binds to CD79B, a protein which is abundantly expressed on the surface of B-cells. Upon internalization and proteolytic cleavage, MMAE binds to tubulin and inhibits its polymerization, resulting in G2/M phase arrest and tumor cell apoptosis.
Route: IV
Extravasation: neutral
==Diseases for which it is used==
*Diffuse large B-cell lymphoma
*High-grade B-cell lymphoma
==Patient drug information==
==History of changes in FDA indication==
*2019-06-10: Accelerated approval in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. (Based on GO29365)
*2023-04-19: Approved with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for 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 (IPI) score of 2 or greater. (Based on POLARIX)
==History of changes in EMA indication==
*2020-01-16: Initial conditional approval
==History of changes in Health Canada indication==
*2020-07-09: Initial notice of compliance with conditions
*2023-01-20: Conditions were met
==History of changes in PMDA indication==
*2021-03-21: Newly indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
*2022-08-24: New indication and a new dosage for the treatment of diffuse large B-cell lymphoma.
==Also known as==
*Code name: DCDS4501A, FCU-2711, RG-7596
*Generic name: polatuzumab vedotin-piiq
*Brand name: Polivy
==References==
Category:Drugs
Category:Intravenous medications
Category:Anti-CD79B antibody-drug conjugates
Category:Microtubule inhibitors
Category:Diffuse large B-cell lymphoma medications
Category:High-grade B-cell lymphoma medications
Category:FDA approved in 2019
Category:EMA approved in 2020
Category:Health Canada approved in 2020
Category:PMDA approved in 2021
Category:Genentech product
Polycythemia

==Initial evaluation==
May consist of:
*CBC with differential
*Pulse oximetry
*Serum erythropoetin
*JAK2 (V617F, exon 12 mutation)
*Comprehensive metabolic panel (CMP)
*Reticulocyte count
*Iron, total iron binding capacity (TIBC), ferritin
*Clinical history of arterial or venous thromboembolism (VTE), stroke, post-bathing pruritis, facial plethora, headache, fatigue, visual changes
===Secondary polycythemia?===
*Smoking
*Chronic lung disease
*Obstructive sleep apnea (OSA)
*Carbon monoxide (CO) exposure
**Home heating: natural gas or oil?
**Carbon monoxide detectors?
**Carboxyhemoglobin
*High altitude environments
*Testosterone use
*Erythropoetin use
*Athletic blood doping/transfusions
*Right to left cardiac shunt
*Dehydration/diuretic use
===Additional considerations===
*Renal ultrasound or other imaging to evaluate for erythropoetin-secreting renal tumor, pheochromocytoma
*Chest x-ray
*Urinalysis
*Family history of high oxygen affinity hemoglobinopathies?
*Cushing's syndrome?
*Congenital polycythemia?
Category:Hematology reference pages
Polycythemia vera - null regimens

Back to Top
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 PV page for regimens that include active anticancer treatment.
=First-line therapy=
==Placebo==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Landolfi et al. 2004 (ECLAP)	1998-2000 	Phase 3 (C)	Aspirin 	Did not meet co-primary endpoint of cumulative rate of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causesHigher cumulative rate of nonfatal myocardial infarction, nonfatal stroke, pulmonary embolism, major venous thrombosis, or death from cardiovascular causes (co-primary endpoint)
No active treatment.
</div>
===References===
# ECLAP: Landolfi R, Marchioli R, Kutti J, Gisslinger H, Tognoni G, Patrono C, Barbui T; European Collaboration on Low-Dose Aspirin in Polycythemia Vera Investigators. Efficacy and safety of low-dose aspirin in polycythemia vera. N Engl J Med. 2004 Jan 8;350(2):114-24. link to original article EuroPMC
Category:Polycythemia vera regimens
Category:Disease-specific pages
Category:Myeloproliferative neoplasms
Category:Null regimens
Ponsegromab (GDF-15)

==Mechanism of action==
GDF-15 inhibitor
==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.
#PROACC-1: Groarke JD, Crawford J, Collins SM, Lubaczewski S, Roeland EJ, Naito T, Hendifar AE, Fallon M, Takayama K, Asmis T, Dunne RF, Karahanoglu I, Northcott CA, Harrington MA, Rossulek M, Qiu R, Saxena AR. Ponsegromab for the Treatment of Cancer Cachexia. N Engl J Med. 2024 Dec 19;391(24):2291-2303. Epub 2024 Sep 14. link to original article EuroPMC NCT05546476
Category:Drugs
Category:Investigational drugs
Category:Stub
Porfimer (Photofrin)

==General information==
Class/mechanism: Photosensitizing agent used in photodynamic therapy (PDT), comprised of a mixture of oligomers formed by ether and ester linkages of up to eight porphyrin units. Light from photodynamic therapy excites porphyrin and results in the propagation of radical reactions, including the formation of superoxide and hydroxyl radicals. Ischemic necrosis due to vascular occlusion thought to be mediated by thromboxane A2 (TXA2) release and has also been observed.Porfimer (Photofrin) package insertPorfimer (Photofrin) package insert (locally hosted backup)
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 such as Micromedex, Lexicomp, or the prescribing information. 
==Patient drug information==
*Porfimer (Photofrin) patient drug information (UpToDate)Porfimer (Photofrin) patient drug information (UpToDate)
==History of changes in EMA indication==
*1993-04-19: EURD
==Also known as==
*Brand name: Photofrin
==References==
Category:Drugs
Category:Intravenous medications
Category:Photosensitizers
Category:FDA approved in 1995
Category:EMA approved in 1993
Pralatrexate (Folotyn)

==General information==
Class/mechanism: Folate analog, antimetabolite, competitive inhibitor of dihydrofolate reductase. Also competitively inhibits polyglutamylation by folylpolyglutamyl synthetase and causes depletion of thymidine.Pralatrexate (Folotyn) package insertPralatrexate (Folotyn) package insert (locally hosted backup)
Route: IV
Extravasation: no information
Supportive care examples:
*Patients should take daily folic acid (example dose: 1 to 1.25 mg PO once per day) starting in the 10-day period before starting therapy, during therapy, and for 30 days after the last dose of Pralatrexate (Folotyn).
*Vitamin B12 1000mcg should be given no less than 10 weeks before the first dose of Pralatrexate (Folotyn) and then every 8 to 10 weeks thereafter.
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 established==
*Peripheral T-cell lymphoma
==Diseases for which it is used==
*Cutaneous T-cell lymphoma
==Patient drug information==
*Pralatrexate (Folotyn) patient drug information (UpToDate)Pralatrexate (Folotyn) patient drug information (UpToDate)
==History of changes in FDA indication==
*2009-09-24: Accelerated approval for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). (Based on PROPEL)
==History of changes in Health Canada indication==
*2018-10-26: Initial notice of compliance with conditions for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
==History of changes in PMDA indication==
*2017-07-03: New approval for the treatment of relapsed or refractory peripheral T-cell lymphoma.
==Also known as==
*Brand names: Difolta, Folotyn
==References==
Category:Drugs
Category:Intravenous medications
Category:Antimetabolites
Category:Antifolates
Category:Cutaneous T-cell lymphoma medications
Category:Peripheral T-cell lymphoma medications
Category:FDA approved in 2009
Category:Health Canada approved in 2018
Category:PMDA approved in 2017