Tags : Myelofibrosis

Pharma

Incyte Collaborates with Cellenkos for CK0804 to Treat Myelofibrosis

Shots: The companies collaborated to evaluate ruxolitinib in combination with CK0804 in patients with MF and plan to initiate a P-Ib study. Incyte will fund the study while operationalized by Cellenkos Cellenkos to receive $20M as licensing fee, ~$294.5M as development, regulatory and commercialization milestones along with royalties on sales of therapies, if approved. Incyte […]Read More

Regulatory

BMS’ Inrebic (fedratinib) Receives Health Canada’s Approval for Patients with

Shots:  The approval is based on JAKARTA and JAKARTA2 clinical trials. JAKARTA study involves assessing Inrebic (500mg) vs PBO for at least 6 cycles in 289 patients in patients with intermediate-2 or high-risk MF, post-polycythemia vera MF or post-essential thrombocythemia MF with splenomegaly and platelet count ≥50 x 109/L The P-II JAKARTA 2 study involves […]Read More

Regulatory

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

Shots: 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 […]Read More

Regulatory

Celgene’s Fedratinib Receives FDA’s Priority Review to NDA Filing for

Shots: Celgene announces the acceptance of Fedratinib’s NDA based on P-III JAKARTA study assessing Fedratinib (400mg/500mg) vs PBO in 289 patients with primary or secondary myelofibrosis across 24 countries The P-III JAKARTA study results: meeting its 1EPs & 2EPs i.e, reduction in spleen volume (35%) & reduction in Total Symptom Score (50%) after six one-month treatment […]Read More