Elmariah on the Evolving Role of Fedratinib
Hany Elmariah, MD, discusses how he sees fedratinib fitting into clincal practice for the treatment of myeloproliferative neoplasms.
Fedratinib (Inrebic) is currently used in clinical practice for the treatment of adults with specific types of myelofibrosis (MF). Specifically, fedratinib is approved for patients with intermediate-2 or high-risk primary MF or secondary MF that has developed from polycythemia vera or essential thrombocythemia.
Fedratinib is a kinase inhibitor that works by blocking the action of the JAK2 protein, which is often overactive or mutated in myelofibrosis. This helps to reduce spleen size and alleviate disease-related symptoms. While it can be used in patients who are newly diagnosed, it is often considered a valuable option for patients who have become resistant to or intolerant of ruxolitinib (Jakafi), the first JAK inhibitor approved for myelofibrosis.
A phase 1 trial investigated the safety and tolerability of fedratinib as maintenance therapy following allogeneic hematopoietic cell transplant (HCT) for myeloproliferative neoplasms (MPNs) or MDS/MPN overlap syndromes. Eleven evaluable patients received fedratinib starting 60 to 100 days posttransplant for up to one year.
While 4 patients withdrew due to non-dose limiting toxicity-related adverse events, no therapy-related deaths occurred. One patient developed severe chronic graft-vs-host disease (GVHD). At a median follow-up of 10.7 months, the median overall survival was not reached, and the median progression-free survival was 12.4 months.
The study concluded that fedratinib at 400 mg daily is safe as post-HCT maintenance, and a phase 2 expansion cohort is currently enrolling to further evaluate its safety and long-term efficacy in preventing relapse and GVHD.
Here, Hany Elmariah, MD, associate member at the Moffitt Cancer Center in the Department of Bone Marrow Transplant and Cellular Immunotherapy, discusses how he sees the role of fedratinib evolving in the MPN treatment landscape following findings from this study.
