Selective JAK inhibitors receive FDA priority review qualification for treatment of myelofibrosis

On June 1, 2021, CTI BioPharma announced that the US FDA has accepted its new drug application (NDA) for the investigational oral kinase inhibitor pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia.

Pacritinib is an oral inhibitor that specifically inhibits JAK2, IRAK1 and CSF1R.

This NDA application is based on the positive results of one phase 2 clinical trial and two phase 3 clinical trials of pacritinib.

▲The molecular structure of Pacritinib (photo source: Anypodetos, Public domain, via Wikimedia Commons)

Myelofibrosis is a type of bone marrow cancer that manifests as the formation of fibrous scar tissue, which can lead to severe thrombocytopenia and anemia, weakness, fatigue, and enlargement of the spleen and liver.

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Reference materials:

[1] CTI BioPharma Announces Acceptance of NDA Granted with Priority Review of Pacritinib for Treatment of Patients with Myelofibrosis.

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