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A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess PK and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as 2nd Line Therapy for Essential Thrombocythemia (SURPASS ET): The Core Study and Its Extension Study

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Trial Profile

A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess PK and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as 2nd Line Therapy for Essential Thrombocythemia (SURPASS ET): The Core Study and Its Extension Study

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Feb 2026

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At a glance

  • Drugs Ropeginterferon alfa-2b (Primary) ; Anagrelide
  • Indications Essential thrombocythaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms SURPASS ET
  • Sponsors PharmaEssentia Corporation

Most Recent Events

  • 13 Jan 2026 According to a PharmaEssentia Corporation media release, Ruben Mesa, M.D., President of Advocate Health's Cancer National Service Line, is the principal investigator of the SURPASS-ET trial.
  • 13 Jan 2026 According to a PharmaEssentia Corporation media release, the USFDA has completed it's filing review of the company's BLA and did not identify any issues. This submission is sufficient to proceed with a substantive review for ropeginterferon alfa-2b-njft for the treatment of adult patients with ET. A PDUFA Date of August 30, 2026 has been given. This sBLA is supported by confirmatory evidence from the North American Phase 2b EXCEED-ET trial and results from the global Phase 3 SURPASS-ET trial.
  • 12 Jan 2026 According to a PharmaEssentia Corporation media release, The FDA's review of supplemental Biologics License Application to expand the ropeginterferon alfa-2b-njft (BESREMi) label to include patients with ET is ongoing.

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