FDA grants Fast Track to Baxter JAK inhibitor
CTI Biopharma has scored a Fast Track designation for its JAK2 inhibitor pacritinib, CTI and its partner Baxter announced. The experimental drug is being reviewed for patients with intermediate or high-risk myelofibrosis. The pursued indication also includes patients with disease or treatment-induced thrombocytopenia, a state in which patients have low platelet levels.
The oral tyrosine kinase inhibitor is being reviewed based on the firm's Phase-III PERSIST trials. The companies said in a statement that pacritinib may have an edge over other JAK inhibitors because it appears to be associated with fewer cases of treatment-stimulated cases of thrombocytopenia.
CTI and Baxter partnered up last year in a worldwide license agreement in which both companies will commercialize the drug in the US, but Baxter will have full commercial rights everywhere else.