JCA Pulse › Ongoing JCA
Ongoing JCAMezigdomide: EU joint clinical assessment
Treatment of adult patients with relapsed or refractory multiple myeloma
- Regulatory review
- CHMP opinion
- EU authorised
- JCA report published
Overview
- Therapy area
- Haematology · Myeloma
- Indication
- Treatment of adult patients with relapsed or refractory multiple myeloma
- Product type
- Chemical
- EMA validation
- 18 Jun 2026
- JCA assessor
- IQWiG, Germany
- Co-assessor
- AOTMiT, Poland
- Regulatory status
- Under EMA review.
- Pivotal evidence
- SUCCESSOR-2 (phase 3, open-label); SUCCESSOR-1 also ongoing (RCT)
Scope
The PICO forecast
JCA Pulse forecasts 3–4 PICOs for Mezigdomide, with 12 candidate comparators. See the populations, comparators and likely outcomes the assessment is set to cover.
Evidence
Fit against the likely scope
Mezigdomide’s pivotal evidence (SUCCESSOR-2) is randomised. Pro scores how well it fits each likely PICO and flags where assessors may push back.
Comparisons
Trials and indirect comparisons
Pro maps every trial likely in the Mezigdomide dossier and projects the indirect comparison each comparator will need.
Countries
National translator and outlook
Germany and Poland 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.
Sources
- European Commission list of ongoing JCAs
- thelancet.com
- ema.europa.eu
- ema.europa.eu
- ema.europa.eu
- ema.europa.eu
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
- EU JCA dossiers and PICO scopingSupport from PICO scoping to the dossier
- JCA PICO scoping: process and preparationHow assessors set the scope
- EU JCA timelineEvery upcoming milestone
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