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Celgene's Inrebic (fedratinib) Receives the US FDA's Approval for Myelofibrosis

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Celgene's Inrebic (fedratinib) Receives the US FDA's Approval for Myelofibrosis

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  • The approval is based on multiple studies including JAKARTA and JAKARTA2. The P-III JAKARTA study involves assessing of Inrebic (400mg) vs PBO in patients with intermediate-2 or high-risk- primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with splenomegaly and a platelet count of ≥50 x 109/L2 prior not treated with JAK inhibitor
  • The P-III JAKARTA study results: @24wks. with 4wks. follow up scan- >35% reduction in spleen volume (37% vs 1%); >50% improvement in TSS as measured by (MFSAF) v2.0 diary (40% vs 9%)
  • Inrebic is an oral kinase inhibitor targeting JAK2 & FLT3- new therapy in nearly a decade for patients affected by rare bone marrow cancer and is gained by Celgene with the acquisition of Impact Biomedicines for $7B

Click here to­ read full press release/ article | Ref: Celgene | Image: Flickr


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