September 23, 2015
CTI BioPharma Corp. today announced their plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Pacritinib, an oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. They are requesting approval for this drug as a treatment for patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (<50,000/uL).
Submission of an NDA after a single Phase 3 trial under accelerated approval, instead of waiting to complete two Phase 3 trials, could potentially reduce time to market by up to 14 months.
For more information about the FDA Accelerated Approval program click here.
The PERSIST-1 trials, which is a randomized trial of Pacritinib against best available therapy in patients with myelofibrosis regardless of platelet counts is ongoing. CTI Biopharma is working in partneship with Baxalta on the development of Pacrinitib.