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JCA Pulse › Ongoing JCA

Ongoing JCA

Pelabresib: EU joint clinical assessment

Splenomegaly or symptoms in adults with primary or secondary myelofibrosis

  1. Regulatory review
  2. CHMP opinion
  3. EU authorised
  4. JCA report published

Overview

Therapy area
Haematology · Myelofibrosis
Indication
Splenomegaly or symptoms in adults with primary or secondary myelofibrosis
Product type
Chemical, Orphan designation
EMA validation
01 Oct 2026
JCA assessor
NoMA, Norway
Co-assessor
University of Tartu, Estonia
Regulatory status
Under EMA review (validated Oct 2026).
Pivotal evidence
MANIFEST-2 (phase 3, double-blind; with ruxolitinib, RCT)
01

Scope

The PICO forecast

JCA Pulse forecasts 1–2 PICOs for Pelabresib, with 2 candidate comparators. See the populations, comparators and likely outcomes the assessment is set to cover.

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02

Evidence

Fit against the likely scope

Pelabresib’s pivotal evidence (MANIFEST-2) is randomised. Pro scores how well it fits each likely PICO and flags where assessors may push back.

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03

Comparisons

Trials and indirect comparisons

Pro maps every trial likely in the Pelabresib dossier and projects the indirect comparison each comparator will need.

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04

Countries

National translator and outlook

Norway and Estonia lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets.

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Sources

Last checked 5 November 2026. Compiled from public sources; check them for the latest position. Forecasts are Evidaxia’s independent view, not official assessments.

From Evidaxia

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