Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Feb;21(5):579-591.
doi: 10.1080/14796694.2025.2454895. Epub 2025 Jan 26.

Real-world treatment patterns and health outcomes for patients with myelofibrosis treated with fedratinib

Francesco Passamonti  1   2 , Siddhi Korgaonkar  3 , Rohan C Parikh  3 , Manoj Chevli  4 , Aylin Yucel  5 , Julien Rombi  6 , Shalon Jones  5 , Dorothy Zissler  5 , Keith L Davis  3 , Samantha Slaff  5
Affiliations

Real-world treatment patterns and health outcomes for patients with myelofibrosis treated with fedratinib

Francesco Passamonti et al. Future Oncol. 2025 Feb.

Abstract

Aim: Assess real-world fedratinib (FEDR) treatment patterns and clinical outcomes in patients with primary or secondary myelofibrosis following discontinuation of ruxolitinib (RUX).

Patients & methods: This study was a retrospective, noninterventional medical record review of patients in Canada, Germany, and the United Kingdom (UK). A total of 70 physicians (primarily hematologist-oncologists [78.6%]) provided data for 196 eligible patients.

Results: Patients were mostly male (62.8%) with primary myelofibrosis (76.5%) and initiated FEDR at a mean age of 67.7 years. Median treatment duration was 11.5 months (median follow-up, 13.8 months), and nearly half (49.5%) of patients initiated FEDR at the label-indicated dose of 400 mg daily. Six months post-initiation, 77.7% and 66.8% of patients experienced symptom and spleen response, respectively. Kaplan-Meier estimates of median progression-free and overall survival from initiation were 23.8 months (95% CI, 21.1-27.6) and 29.8 months (95% CI, 23.9-NE), respectively.

Conclusion: These findings demonstrate real-world FEDR effectiveness among patients with myelofibrosis who discontinued RUX.

Keywords: Myelofibrosis; fedratinib; medical record review; real-world evidence; ruxolitinib; survival analysis.

Plain language summary

What is this summary about?Myelofibrosis (MF) is a rare blood cancer that can cause unhealthy spleen growth and symptoms, such as feeling tired, loss of appetite, bone pain, and fever. This is a summary of an article that reviewed medical records of patients with MF from treatment centers in Canada, Germany, and the United Kingdom (UK). The study looked at people who had been taking a medication called fedratinib (FEDR) for their MF after they had stopped taking a different medication called ruxolitinib (RUX). Many of the people stopped taking RUX because their MF got worse within a few years. The study wanted to see if taking FEDR reduced symptoms and spleen size for people with MF after they stopped taking RUX.What were the results?After at least 6 months of taking FEDR, 77.7% of the people in the study had fewer symptoms, and 66.8% of people in the study had a decrease in spleen size or no spleen growth. Additionally, most people taking FEDR after discontinuing RUX went nearly 2 years without their MF symptoms or illness getting worse.What do the results mean?These results suggest that FEDR is an effective treatment for people with MF who have stopped taking RUX.

PubMed Disclaimer

Conflict of interest statement

MC, AY, SJ, DZ, and SS are employees of Bristol Myers Squibb. SK, RCP, JR, and KLD are full-time employees of RTI Health Solutions, an independent nonprofit research organization, which was retained by Bristol Myers Squibb to conduct the research that is the subject of this manuscript. Their compensation is unconnected to the studies on which they work. Medical writing support was provided by Gabrielle Dardis, PhD, and Madison Walker, MPH, of RTI Health Solutions, and editing support was provided by John Forbes of RTI Health Solutions, as part of a contract with Bristol Myers Squibb.

Figures

Figure 1.
Figure 1.
MF-Related symptoms while receiving FEDR treatment.
Figure 2.
Figure 2.
Change in spleen size while receiving fedratinib treatment.
Figure 3.
Figure 3.
Kaplan-Meier analyses of rw-PFS and OS from fedratinib initiation.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. O’Sullivan JM, Harrison CN.. Myelofibrosis: clinicopathologic features, prognosis, and management. Clin Adv Hematol Oncol. 2018. Feb;16(2):121–131. - PubMed
    1. Titmarsh GJ, Duncombe AS, McMullin MF, et al. How common are myeloproliferative neoplasms? A systematic review and meta-analysis. Am J Hematol. 2014. Jun;89(6):581–587. doi: 10.1002/ajh.23690 - DOI - PubMed
    1. Thiele J, Kvasnicka HM, Orazi A, et al. The international consensus classification of myeloid neoplasms and acute leukemias: myeloproliferative neoplasms. Am J Hematol. 2023. Jan;98(1):166–179. doi: 10.1002/ajh.26751 - DOI - PubMed
    1. Tefferi A. Primary myelofibrosis: 2021 update on diagnosis, risk-stratification and management. Am J Hematol. 2021. Jan;96(1):145–162. doi: 10.1002/ajh.26050 - DOI - PubMed
    1. Iurlo A, Cattaneo D. Treatment of myelofibrosis: old and new strategies. Clin Med Insights Blood Disord. 2017;10:1179545X17695233. doi: 10.1177/1179545X17695233 - DOI - PMC - PubMed

MeSH terms

LinkOut - more resources