JCA Pulse › JCA report published
JCA report publishedLurbinectedin (Zepzelca): EU joint clinical assessment
With atezolizumab, maintenance treatment of adults with extensive-stage small cell lung cancer not progressed after first-line atezolizumab, carboplatin and etoposide
- Regulatory review
- CHMP opinion
- EU authorised
- JCA report published
Overview
- Company
- Pharma Mar
- Therapy area
- Solid tumours · Lung
- Indication
- With atezolizumab, maintenance treatment of adults with extensive-stage small cell lung cancer not progressed after first-line atezolizumab, carboplatin and etoposide
- Product type
- Orphan designation
- EC marketing authorisation
- 29 May 2026
- JCA report published
- 8 Jul 2026
- JCA assessor
- IQWiG, Germany
- Co-assessor
- INFARMED, Portugal
- Pivotal evidence
- IMforte (phase 3, n=483; lurbinectedin + atezolizumab vs atezolizumab maintenance)
Scope
From the published report
The JCA report set out 1 PICOs across 1 population.
A single PICO, reflecting a narrowly specified population and one comparator across member states.
Evidence
How the evidence covered the scope
Comparative evidence informed 1 of the 1 PICOs. Pro breaks down how the evidence covered each one, and what it means for later submissions.
Countries
National translator and outlook
Germany and Portugal lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets, with 10 national records already in place.
Next milestones
- 10 Nov 2026G-BA oral hearing · Germany · source
- Nov 2026Assessment board recommendation expected · Austria · source
- Mid-Dec 2026G-BA resolution expected · Germany · source
- 1 Oct 2026G-BA assessment published · Germany · source
- 17 Sep 2026HAS declined early access · France · source
- 13 Oct 2026NICE terminated appraisal published (TA1198) · United Kingdom · source
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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