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Ongoing JCA

Taletrectinib: EU joint clinical assessment

Treatment of adults with ROS1-positive advanced NSCLC

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

Overview

Therapy area
Solid tumours · Lung
Indication
Treatment of adults with ROS1-positive advanced NSCLC
Product type
Chemical
EMA validation
26 Mar 2026
JCA assessor
TLV, Sweden
Co-assessor
IQWiG, Germany
Regulatory status
Under EMA review; no CHMP opinion found as of 5 Nov 2026.
Pivotal evidence
TRUST-I (China) + TRUST-II (global), phase 2 (Single-arm)
01

Scope

The PICO forecast

JCA Pulse forecasts 2 PICOs for Taletrectinib, with 5 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

Taletrectinib rests on TRUST-I, evidence without a randomised comparator. Pro shows which likely PICOs it can answer, and where the gaps sit.

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03

Comparisons

Trials and indirect comparisons

Pro maps every trial likely in the Taletrectinib dossier and projects the indirect comparison each comparator will need.

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04

Countries

National translator and outlook

Sweden and Germany 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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Next milestones

  • 12 Nov 2026NICE scope consultation closes · 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

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