Therapy Detail

Therapy Name SAR302503
Therapy Description

Fedratinib (SAR302503) binds and inhibits JAK2, FLT3, and RET kinases, which may inhibit cell proliferation and tumor growth (PMID: 17541402).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
SAR302503 Fedratinib TG101348 FLT3 Inhibitor 50 JAK2 Inhibitor - ATP competitive 14 RET Inhibitor 36 Fedratinib (SAR302503) binds and inhibits JAK2, FLT3, and RET kinases, which may inhibit cell proliferation and tumor growth (PMID: 17541402).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown myelofibrosis not applicable SAR302503 Phase III Actionable In a Phase III trial, Fedratinib (SAR302503) 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). 26181658
JAK2 R867Q hematologic cancer decreased response SAR302503 Preclinical - Cell culture Actionable In a preclinical study, immune cells expressing JAK2 R867Q demonstrated decreased response to Fedratinib (SAR302503) in culture (PMID: 24398328). 24398328
JAK2 V617F JAK2 R938L hematologic cancer resistant SAR302503 Preclinical - Cell culture Actionable In a preclinical study, immune cells expressing the JAK2 V617F and JAK2 R938L double mutation demonstrated resistance to fedratinib (SAR302503) in culture (PMID: 21926964). 21926964
CALR L367fs myelofibrosis predicted - sensitive SAR302503 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 Fedratinib (SAR302503) (PMID: 24645956). 24645956
JAK2 V617F JAK2 I960V hematologic cancer resistant SAR302503 Preclinical - Cell culture Actionable In a preclinical study, immune cells expressing the JAK2 V617F and JAK2 I960V double mutation demonstrated resistance to Fedratinib (SAR302503) in culture (PMID: 21926964). 21926964
Clinical Trial Phase Therapies Title Recruitment Status
NCT03755518 Phase III SAR302503 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