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Therapy Name	Pacritinib
Synonyms
Therapy Description	Vonjo (pacritinib) is an inhibitor of JAK2 and FLT3, with activity against JAK2 V617F and FLT3 ITD, which potentially increases tumor cell apoptosis, induces cell cycle arrest, and decreases tumor growth (PMID: 22829080, PMID: 21691275). Vonjo (pacritinib) is FDA approved for use in patients with primary or secondary myelofibrosis (FDA.gov).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Pacritinib	Vonjo	SB1518\|SB-1518\|SB 1518	FLT3 Inhibitor 69 JAK2 Inhibitor - ATP competitive 15	Vonjo (pacritinib) is an inhibitor of JAK2 and FLT3, with activity against JAK2 V617F and FLT3 ITD, which potentially increases tumor cell apoptosis, induces cell cycle arrest, and decreases tumor growth (PMID: 22829080, PMID: 21691275). Vonjo (pacritinib) is FDA approved for use in patients with primary or secondary myelofibrosis (FDA.gov).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
FLT3 exon 14 ins	acute myeloid leukemia	predicted - sensitive	Pacritinib	Preclinical - Cell line xenograft	Actionable	In a preclinical study, Vonjo (pacritinib) induced apoptosis and inhibited proliferation of acute myeloid leukemia cells harboring a FLT3-ITD mutation in culture, and inhibited tumor growth and induced tumor regression in cell line xenograft models (PMID: 22829080).	22829080
JAK3 V718L	esophagus adenocarcinoma	sensitive	Pacritinib	Preclinical - Patient cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) inhibited viability of cells derived from the brain metastases of a patient with esophagus adenocarcinoma harboring JAK3 V718L in culture (PMID: 38985431).	38985431
FLT3 D835H	hematologic cancer	sensitive	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) inhibited viability in a transformed cell line expressing FLT3 D835H in culture (PMID: 31102119).	31102119
FLT3 D835Y	hematologic cancer	sensitive	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) inhibited kinase activity and viability in a transformed cell line expressing FLT3 D835Y in culture (PMID: 31102119).	31102119
FLT3 exon 14 ins	acute myeloid leukemia	predicted - sensitive	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) inhibited viability in acute myeloid leukemia cell lines harboring a FLT3-ITD mutation in culture (PMID: 31102119).	31102119
FLT3 exon 14 ins	hematologic cancer	sensitive	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) inhibited kinase activity, phosphorylation of Flt3 and Stat5, and viability in a transformed cell line expressing a FLT3-ITD mutation in culture (PMID: 31102119).	31102119
FLT3 exon 14 ins FLT3 D835H	hematologic cancer	sensitive	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) inhibited viability in a transformed cell line expressing a FLT3-ITD mutation and FLT3 D835H in culture (PMID: 31102119).	31102119
FLT3 exon 14 ins FLT3 D835V	hematologic cancer	resistant	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD and FLT3 D835V demonstrated resistance to Vonjo (pacritinib) in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 D835Y	hematologic cancer	conflicting	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD and FLT3 D835Y demonstrated resistance to Vonjo (pacritinib) in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 D835Y	hematologic cancer	conflicting	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) inhibited phosphorylation of Flt3 and Stat5 and viability in a transformed cell line expressing a FLT3-ITD mutation and FLT3 D835Y in culture (PMID: 31102119).	31102119
FLT3 exon 14 ins FLT3 D835Y	acute myeloid leukemia	sensitive	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) inhibited viability in an acute myeloid leukemia cell line harboring a FLT3-ITD mutation and FLT3 D835Y in culture (PMID: 31102119).	31102119
FLT3 exon 14 ins FLT3 D839G	hematologic cancer	resistant	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD and FLT3 D839G demonstrated resistance to Vonjo (pacritinib) in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 F691L	hematologic cancer	conflicting	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) inhibited phosphorylation of Flt3 and Stat5 and viability in a transformed cell line expressing a FLT3-ITD mutation and FLT3 F691L in culture (PMID: 31102119).	31102119
FLT3 exon 14 ins FLT3 F691L	hematologic cancer	conflicting	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD and FLT3 F691L demonstrated resistance to Vonjo (pacritinib) in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 F691L FLT3 D835Y	hematologic cancer	resistant	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD, FLT3 F691L, and FLT3 D835Y demonstrated resistance to Vonjo (pacritinib) in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 F691L FLT3 Y842H	hematologic cancer	resistant	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD, FLT3 F691L, and FLT3 Y842H demonstrated resistance to Vonjo (pacritinib) in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins FLT3 Y842H	hematologic cancer	resistant	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, transformed cells expressing FLT3-ITD and FLT3 Y842H demonstrated resistance to Vonjo (pacritinib) in culture (PMID: 34768286).	34768286
FLT3 exon 14 ins JAK2 V617F	hematologic cancer	predicted - sensitive	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) treatment decreased cell proliferation and downstream signaling in transformed hematologic cells expressing a FLT3-ITD mutation and JAK2 V617F in culture but may not be capable of fully inhibiting Flt3 and Jak signaling at clinically achievable concentrations (PMID: 33149267).	33149267
FLT3 exon 14 ins JAK3 V722I	hematologic cancer	decreased response	Pacritinib	Preclinical - Cell culture	Actionable	In a preclinical study, Vonjo (pacritinib) treatment decreased cell proliferation and Akt and Erk phosphorylation, but did not fully inhibit Stat5 phosphorylation in transformed hematologic cells expressing a FLT3-ITD mutation and JAK3 V722I and was less effective compared to treatment with the combination of a FLT3 inhibitor and a JAK inhibitor in culture (PMID: 33149267).	33149267

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02251821	Phase II	Fludarabine Tacrolimus Mycophenolate mofetil Busulfan Pacritinib Momelotinib Melphalan Methotrexate Ruxolitinib Cyclophosphamide	JAK-2 Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis	Active, not recruiting	USA	0
NCT03645824	Phase II	Pacritinib	Myelofibrosis Treated With Pacritinib Before aSCT. (HOVON134MF) (HOVON134MF)	Active, not recruiting	NLD \| BEL	0
NCT06303193	Phase I	Pacritinib	Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms	Not yet recruiting	USA	0
NCT03165734	Phase III	Ruxolitinib Hydroxyurea Pacritinib Danazol	A Phase 3 Study of Pacritinib in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis (PACIFICA)	Recruiting	USA \| ROU \| POL \| ITA \| ISR \| HUN \| GBR \| FRA \| ESP \| DEU \| CZE \| CAN \| BGR \| AUS	9
NCT04858256	Phase II	Pacritinib	Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms	Recruiting	USA	0
NCT02277093	Phase II	Pacritinib	Pacritinib to Inhibit JAK/STAT Signaling in Refractory Colorectal Cancer	Terminated	USA	0
NCT02469415	Phase II	Decitabine Azacitidine Pacritinib	Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS)	Terminated	USA	0
NCT03601819	Phase I	Pacritinib	Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders	Terminated	USA	0
NCT04635059	Phase II	Pacritinib	Pacritinib for Biochemical Relapse After Definitive Treatment for Prostate Cancer (BLAST)	Terminated	USA	0

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