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JCA Pulse › Ongoing JCA

Ongoing JCA

Lirafugratinib: EU joint clinical assessment

Previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma

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

Overview

Company
Elevar Therapeutics
Therapy area
Solid tumours · Gastrointestinal
Indication
Previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma
Product type
Chemical, Orphan designation
EMA validation
01 Oct 2026
JCA assessor
TLV, Sweden
Co-assessor
Federation of Social Insurances, Austria
Regulatory status
Under EMA review (validated Oct 2026).
Pivotal evidence
ReFocus (phase 1/2, Single-arm)
01

Scope

The PICO forecast

JCA Pulse forecasts 2 PICOs for Lirafugratinib, with 3 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

Lirafugratinib rests on ReFocus, evidence without a randomised comparator. Pro shows which likely PICOs it can answer, and where the gaps sit.

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03

Comparisons

Trials and indirect comparisons

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

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04

Countries

National translator and outlook

Sweden and Austria 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.

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