FDA expands essential thrombocythemia care - Summary - MDSpire
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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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Objective:

To announce the FDA approval of ropeginterferon alfa-2b-njft for the treatment of adults with essential thrombocythemia.

Approach:
  • FDA Approval: The FDA approved ropeginterferon alfa-2b-njft for adults with essential thrombocythemia, including newly diagnosed patients.
  • Clinical Trial Data: Approval based on data from the global phase 3 SURPASS ET trial showing higher durable response rates compared to anagrelide.
Key Findings:
  • First new FDA-approved treatment for essential thrombocythemia in nearly 30 years.
  • Ropeginterferon alfa-2b-njft reduces thromboembolic events over 12 months.
  • Durable responses based on modified European Leukemia Net criteria.
Interpretation:

Ropeginterferon alfa-2b-njft is intended to lower platelet counts and disease burden.

Limitations:
  • Boxed warning for potentially fatal neuropsychiatric, autoimmune, ischemic, and infectious disorders.
  • Contraindications include severe depression, hypersensitivity to interferons, and active serious autoimmune disease.
Conclusion:

Ropeginterferon alfa-2b-njft is expected to be available in the US immediately following approval.

Sources:

Original Source(s)

FDA expands essential thrombocythemia care

  • by Kathryn Wighton

  • September 1, 2026

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