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# Sumitomo Pharma Gets Fast Track Status for Nuvisertib
- URL: https://www.fdaweb.com/sumitomo-pharma-gets-fast-track-status-for-nuvisertib/
- Published: 2025-06-16T12:00:00.000Z
- Updated: 2026-09-14T15:14:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159367

FDA has granted Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis (MF). Nuvisertib is described as an oral, investigational, highly selective inhibitor of PIM1 kinase. Sumitomo says it has demonstrated clinical activity including symptom and spleen responses correlating with cytokine modulation in preliminary data from Phase 1/2 data presented at the European Hematology Association 2025 Congress in Milan, Italy. 

MF, a serious and rare type of blood cancer, is characterized by the buildup of fibrous tissues in the bone marrow which is caused by dysregulation in the Janus-associated kinase signaling pathway, according to the company. The clinical manifestations of MF include an enlarged spleen, debilitating symptoms and reduction in hemoglobin and platelets.