Drug news
CTI Pharma and Baxalta complete rolling submission to FDA for pacritinib as a treatment for myelofibrosis
CTI BioPharma and Baxalta announced the completion of the rolling submission of the US NDA for the JAK inhibitor pacritinib, for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of <50,000/µL – a specific patient population for which there is an existing unmet medical need. The companies are seeking accelerated approval and have requested a Priority Review of the application.
Comment: Pacritinib may offer an advantage over other JAK inhibitors through effective treatment of symptoms while having less treatment-emergent thrombocytopenia and anaemia than has been seen in currently approved and in-development JAK inhibitors.