CTI BioPharma’s Pacritinib Gets Priority Review for Myelofibrosis
The FDA has granted a Priority Review for CTI BioPharma’s pacritinib for treating myelofibrosis patients with severe thrombocytopenia, a condition marked by abnormally low levels of blood platelets.
The company’s New Drug Application (NDA) for the Janus kinase inhibitor was supported by positive results from two phase 3 trials and a phase 2 trial.
The FDA has set a target action date of Nov. 30 and does not plan to hold an advisory committee meeting to discuss the NDA, the drugmaker said.
The company will be “well-positioned” for a U.S. launch of pacritinib late this year, according to its CEO Adam R. Craig.