CTI BioPharma Corp. said it plans to submit a new drug application to FDA following a productive pre-NDA meeting for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R.
The company expects to submit the NDA in the fourth quarter of 2015 and to request faster approval for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter.
The NDA will be based primarily on data from the PERSIST-1 phase 3 trial – as well as data from Phase 1 and 2 studies of pacritinib – and additional information requested by FDA, including a separate study report and datasets for the specific patient population with low platelet counts of less than 50,000 per microliter for whom there are no approved drugs.
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.
