Posted by Michael Wonder on 01 Dec 2021
CTI BioPharma announces extension of FDA review period for pacritinib in myelofibrosis with severe thrombocytopenia
30 November 2021 - CTI BioPharma today announced the U.S. FDA has extended the review period for the new drug application for pacritinib for the treatment of adult patients with intermediate or high risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a baseline platelet count of <50 × 109/L.
The Prescription Drug User Fee Act action date has been extended by three months to 28 February 2022.
