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Home » FDA Approves CTI Biopharma’s Vonjo for Rare Bone Marrow Disorders
FDA Approves CTI Biopharma’s Vonjo for Rare Bone Marrow Disorders
The FDA has granted CTI BioPharma’s Vonjo (pacritinib) accelerated approval for treating adults with intermediate- or high-risk myelofibrosis, rare forms of bone marrow disorders.
The approval was supported by a 63-person phase 3 trial in which nine patients given Vonjo showed a 35 percent or greater spleen volume reduction compared with just one patient in the standard treatment group.
Under the terms of the accelerated approval, the FDA said CTI BioPharma must conduct a follow-up confirmatory trial to prove that spleen volume reduction actually causes a clinical benefit.
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