CTI BioPharma’s Vonjo (pacritinib) Receives the US FDA’s Accelerated Approval for the Treatment of Myelofibrosis and Thrombocytopenia
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- The accelerated approval was based on the efficacy results from the P-III (PERSIST-2) study to evaluate Vonjo (200mg, bid, 400mg, qd) vs BAT in a ratio (1:1:1) in patients with myelofibrosis with a platelet count below 50 × 10^9/L
- The results showed that the patients treated with pacritinib 200mg, bid achieved a 29% reduction in spleen volume of at least 35% vs 3%. Additionally, the company is expected to complete (PACIFICA) trial in mid-2025
- Vonjo is an oral kinase inhibitor with specificity for JAK2 & IRAK1 without inhibiting JAK1. The company has launched patient support program, CTI Access to provides reimbursement & financial assistance programs for eligible patients
Ref: CTI BioPharma | Image: CTI
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