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FDA expands essential thrombocythemia care

Phase 3 SURPASS ET data showed higher durable response rates with ropeginterferon alfa-2b-njft than with anagrelide.

  • By

  • Kathryn Wighton

  • September 1, 2026

  • 2 min

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Clinical Report: FDA expands essential thrombocythemia care

Overview

The FDA has approved ropeginterferon alfa-2b-njft for adults with essential thrombocythemia, based on data from the SURPASS ET trial, which demonstrated higher durable response rates compared to anagrelide.

Background

Essential thrombocythemia (ET) is a chronic blood cancer characterized by excessive platelet production. The recent FDA approval of ropeginterferon alfa-2b-njft is based on data from the SURPASS ET trial.

Data Highlights

StudyDurable Response RateThromboembolic Events Reduction
SURPASS ET37.4% (ropeginterferon) vs 3.6% (anagrelide)Reduced over 12 months

Key Findings

  • FDA approved ropeginterferon alfa-2b-njft for ET treatment.
  • Approval includes newly diagnosed patients without prior cytoreductive therapy.
  • Durable response rates were higher with ropeginterferon compared to anagrelide.
  • Treatment reduced thromboembolic events over 12 months.
  • Boxed warning for potential severe side effects associated with interferon alfa products.

Clinical Implications

Monitoring for potential severe side effects is essential due to the boxed warning associated with this therapy.

Conclusion

The approval of ropeginterferon alfa-2b-njft provides a new treatment option for essential thrombocythemia.

Related Resources & Content

  1. PharmaEssentia USA Corporation, FDA, 2026 -- FDA Approves Treatment for Essential Thrombocythemia
  2. The ASCO Post, 2026 -- FDA Approves Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia
  3. NCCN Guidelines Insights, 2026 -- Myeloproliferative Neoplasms
  4. The ASCO Post — How I Work up the Patient with Thrombocytosis
  5. The ASCO Post — Conference Highlights From the 2018 American Society of Hematology Annual Meeting & Exposition
  6. Blood Cancer Journal — A Study of 1,000 Patients with Essential Thrombocythemia: Insights from the Florence-CRIMM Cohort
  7. FDA Approves Treatment for Essential Thrombocythemia
  8. FDA Approves Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia
  9. NCCN Guidelines® Insights: Myeloproliferative Neoplasms, Version 2.2026 - PubMed
  10. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial | Blood | American Society of Hematology

Original Source(s)

FDA expands essential thrombocythemia care

  • by Kathryn Wighton

  • September 1, 2026

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