JCA Pulse › JCA report published
JCA report publishedTarlatamab (Imdylltra): EU joint clinical assessment
Adults with extensive-stage small cell lung cancer progressing on or after first-line platinum-based chemotherapy
- Regulatory review
- CHMP opinion
- EU authorised
- JCA report published
Overview
- Company
- Amgen
- Therapy area
- Solid tumours · Lung
- Indication
- Adults with extensive-stage small cell lung cancer progressing on or after first-line platinum-based chemotherapy
- Product type
- Orphan designation
- EC marketing authorisation
- 29 May 2026
- JCA report published
- 8 Jul 2026
- JCA assessor
- IQWiG, Germany
- Co-assessor
- NCPHP, Hungary
- Pivotal evidence
- DeLLphi-304 (pivotal trial; direct comparison with topotecan)
Scope
From the published report
The JCA report set out 7 PICOs across 4 populations.
Four populations split by platinum sensitivity (treatment-free interval under or over 3 months) and suitability for platinum rechallenge (6-month cut-off). Comparators: topotecan, CAV, and platinum-etoposide rechallenge.
Evidence
How the evidence covered the scope
Comparative evidence informed 7 of the 7 PICOs. Pro breaks down how the evidence covered each one, and what it means for later submissions.
Countries
National translator and outlook
Germany and Hungary lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets, with 9 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
- 24 Feb 2027Medicines Council decision expected · Denmark · source
- 16 Oct 2026Medicines Council assessment started · Denmark · source
- 8 Oct 2026NCPE rapid review: full HTA recommended · Ireland · source
- 1 Oct 2026G-BA assessment published · Germany · source
- 10 Nov 2026NICE committee meeting (second line, ID6617) · United Kingdom · source
- 13 Jan 2027NICE guidance expected (ID6617) · 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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