Therapy Detail

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Therapy Name Fedratinib
Synonyms
Therapy Description

Inrebic (fedratinib) binds and inhibits JAK2, FLT3, and RET kinases, which may inhibit cell proliferation and tumor growth (PMID: 17541402). Inrebic (fedratinib) is FDA approved for use in patients with myelofibrosis (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Fedratinib Inrebic SAR302503|TG101348 FLT3 Inhibitor 55 JAK2 Inhibitor - ATP competitive 14 RET Inhibitor 39 Inrebic (fedratinib) binds and inhibits JAK2, FLT3, and RET kinases, which may inhibit cell proliferation and tumor growth (PMID: 17541402). Inrebic (fedratinib) is FDA approved for use in patients with myelofibrosis (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
JAK2 V617F JAK2 G935R hematologic cancer resistant Fedratinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing the JAK2 V617F and JAK2 G935R double mutation demonstrated resistance to Inrebic (fedratinib) in culture (PMID: 21926964). 21926964
JAK2 V617F JAK2 M929I hematologic cancer predicted - sensitive Fedratinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing the JAK2 V617F and JAK2 M929I double mutation were sensitive to treatment with Inrebic (fedratinib) in culture, demonstrating growth inhibition (PMID: 21926964). 21926964
JAK2 V617F JAK2 Y931C JAK2 F1061W Advanced Solid Tumor resistant Fedratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing JAK2 V617F, Y931C and F1061W demonstrated resistance to Inrebic (fedratinib) treatment in culture (PMID: 26419724). 26419724
CALR L367fs myelofibrosis predicted - sensitive Fedratinib Case Reports/Case Series Actionable In a clinical study, two myelofibrosis patients harboring CALR L367fs (reported as L367fs*46 for patient 1 and L367fs*48 for patient 2) and wild-type JAK2 demonstrated a greater than 50% reduction in spleen size following treatment with Inrebic (fedratinib) (PMID: 24645956). 24645956
JAK2 V617F JAK2 Y931C JAK2 S1025C Advanced Solid Tumor resistant Fedratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing JAK2 V617F, Y931C and S1025C demonstrated resistance to Inrebic (fedratinib) treatment in culture (PMID: 26419724). 26419724
JAK2 V617F JAK2 E985K hematologic cancer resistant Fedratinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing the JAK2 V617F and JAK2 E985K double mutation demonstrated resistance to Inrebic (fedratinib) in culture (PMID: 21926964). 21926964
JAK2 V617F JAK2 Y931C hematologic cancer resistant Fedratinib Preclinical - Cell culture Actionable In a preclinical study, cells expressing the JAK2 V617F and JAK2 Y931C double mutation demonstrated resistance to Inrebic (fedratinib) in culture (PMID: 21926964). 21926964
JAK2 V617F JAK2 Y931C JAK2 Y1045W Advanced Solid Tumor resistant Fedratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing JAK2 V617F, Y931C and Y1045W demonstrated resistance to Inrebic (fedratinib) treatment in culture (PMID: 26419724). 26419724
JAK2 V617F JAK2 Y931C Advanced Solid Tumor sensitive Fedratinib Preclinical - Cell culture Actionable In a preclinical study, Inrebic (fedratinib) treatment inhibited colony formation and proliferation of transformed cells expressing JAK2 V617F and Y931C in culture (PMID: 26419724). 26419724
JAK2 V617F JAK2 R938L hematologic cancer resistant Fedratinib Preclinical - Cell culture Actionable In a preclinical study, immune cells expressing the JAK2 V617F and JAK2 R938L double mutation demonstrated resistance to Inrebic (fedratinib) in culture (PMID: 21926964). 21926964
JAK2 R867Q hematologic cancer decreased response Fedratinib Preclinical - Cell culture Actionable In a preclinical study, immune cells expressing JAK2 R867Q demonstrated decreased response to Inrebic (fedratinib) in culture (PMID: 24398328). 24398328
Unknown unknown myelofibrosis not applicable Fedratinib FDA approved Actionable In a Phase III trial (JAKARTA) that supported FDA approval, Inrebic (fedratinib) demonstrated both clinical benefits and toxicity in myelofibrosis patients, resulting in symptom response rates at week 24 of 36% (33/91), 34% (31/91), and 7% (6/85) in the Fedratinib (SAR302503) 400 mg, 500 mg, and placebo groups, respectively (P<.001) (PMID: 26181658; NCT01437787). 26181658 detail...
JAK2 rearrange myeloid neoplasm sensitive Fedratinib Guideline Actionable Inrebic (fendratinib) is included in guidelines for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring a JAK2 rearrangement (NCCN.org). detail...
JAK2 V617F JAK2 I960V hematologic cancer resistant Fedratinib Preclinical - Cell culture Actionable In a preclinical study, immune cells expressing the JAK2 V617F and JAK2 I960V double mutation demonstrated resistance to Inrebic (fedratinib) in culture (PMID: 21926964). 21926964
JAK2 V617F JAK2 Y931C JAK2 V1075F Advanced Solid Tumor resistant Fedratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing JAK2 V617F, Y931C and V1075F demonstrated resistance to Inrebic (fedratinib) treatment in culture (PMID: 26419724). 26419724

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03755518 Phase III Fedratinib An Efficacy and Safety Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib (FREEDOM) Recruiting


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