BMS' Inrebic (fedratinib) Receives EC's Approval for Patients with Newly Diagnosed and Previously Treated Myelofibrosis
Shots:
- The EC approval is based on JAKARTA and JAKARTA2 studies. The pivotal JAKARTA study involves assessing Inrebic (500mg) vs PBO in 289 patients with intermediate-2 or high-risk primary or secondary myelofibrosis with splenomegaly
- The P-II JAKARTA 2 study involves assessing of Inrebic (400mg- qd) in 97 patients with intermediate or high-risk primary or secondary myelofibrosis with splenomegaly previously treated with ruxolitinib
- Inrebic demonstrated spleen and symptom response in myelofibrosis patients where treatment with ruxolitinib has failed- who are intolerant to ruxolitinib or who are JAK inhibitor naïve. Inrebic is an oral kinase inhibitor with activity against JAK2 and FLT3
Ref: Businesswire | Image: BMS
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