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Ongoing JCA

Zamtocabtagene autoleucel: EU joint clinical assessment

Treatment of adults with large B-cell lymphoma

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

Overview

Therapy area
Haematology · Lymphoma
Indication
Treatment of adults with large B-cell lymphoma
Product type
ATMP, Orphan designation
EMA validation
26 Mar 2026
JCA assessor
ZIN, The Netherlands
Co-assessor
NCPE, Ireland
Regulatory status
Under EMA review; no CHMP opinion found as of 5 Nov 2026.
Pivotal evidence
DALY 2-EU (randomised phase 2, open-label, 12 EU countries, RCT (phase 2))
01

Scope

The PICO forecast

JCA Pulse forecasts 2–3 PICOs for Zamtocabtagene autoleucel, with 6 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

Zamtocabtagene autoleucel’s pivotal evidence (DALY 2-EU) 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 Zamtocabtagene autoleucel dossier and projects the indirect comparison each comparator will need.

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04

Countries

National translator and outlook

Netherlands and Ireland lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets, with 1 national record already in place.

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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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