CTI's Approval Prospects For Pacritinib In Myelofibrosis Look To Be Improving
Firm publishes final data from a Phase III study showing the safety-troubled JAK2/FLT3 inhibitor performs better than Jakafi in reducing spleen size. Ongoing dose-finding study will determine the regulatory path forward.
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CTI BioPharma has had a bumpy ride with pacrotinib, its investigational treatment for patients with myelofibrosis who have thrombocytopenia. But it has persevered and should learn this week whether the European Medicines Agency will recommend that the product be approved for the sale across the EU. Pacritinib, J&J's apalutamide, and AEterna Zentaris's macimorelin are among a handful of products reaching the end of the approval process.
With the commercial opportunity in the myelofibrosis market expected to double to over $1bn in the next five years, competition to Incyte/Novartis's Jakafi seems further away than ever as CTI BioPharma pulls the European regulatory filing for pacritinib.