JCA Pulse › Ongoing JCA
Ongoing JCACosibelimab: EU joint clinical assessment
Metastatic or locally advanced cutaneous squamous cell carcinoma
- Regulatory review
- CHMP opinion
- EU authorised
- JCA report published
Overview
- Company
- Checkpoint Therapeutics
- Therapy area
- Solid tumours · Skin
- Indication
- Metastatic or locally advanced cutaneous squamous cell carcinoma
- Product type
- Biological
- EMA validation
- 21 May 2026
- JCA assessor
- IQWiG, Germany
- Co-assessor
- HAS, France
- Regulatory status
- Under EMA review. FDA approved Dec 2024.
- Pivotal evidence
- CK-301-101 (phase 1, registration cohorts, Single-arm)
Scope
The PICO forecast
JCA Pulse forecasts 1–2 PICOs for Cosibelimab, with 2 candidate comparators. See the populations, comparators and likely outcomes the assessment is set to cover.
Evidence
Fit against the likely scope
Cosibelimab rests on CK-301-101, evidence without a randomised comparator. Pro shows which likely PICOs it can answer, and where the gaps sit.
Comparisons
Trials and indirect comparisons
Pro maps every trial likely in the Cosibelimab dossier and projects the indirect comparison each comparator will need.
Countries
National translator and outlook
Germany and France lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets.
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
- 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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