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Ongoing JCA

Ensartinib (Gevalka): EU joint clinical assessment

Treatment of adult patients with ALK-positive advanced NSCLC

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

Overview

Company
SFL Pharmaceuticals / Betta
Therapy area
Solid tumours · Lung
Indication
Treatment of adult patients with ALK-positive advanced NSCLC
Product type
Chemical
EMA validation
27 Nov 2025
JCA assessor
Federation of Social Insurances, Austria
Co-assessor
AEMPS, Spain
Regulatory status
CHMP positive 17 Sep 2026: ALK-inhibitor-naive; and post-crizotinib. EC decision pending at last check.
Latest
Awaiting EU authorisation; national HTA not started.
Pivotal evidence
eXalt3 (phase 3, open-label) + single-arm post-crizotinib data (RCT (1L); single-arm (2L))
01

Scope

The PICO forecast

JCA Pulse forecasts 2–3 PICOs for Ensartinib, with 8 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

Ensartinib’s pivotal evidence (eXalt3) is randomised. Pro scores how well it fits each likely PICO and flags where assessors may push back.

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03

Comparisons

Trials and indirect comparisons

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

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04

Countries

National translator and outlook

Austria and Spain lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets.

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Next milestones

  • 17 Sep 2026CHMP positive opinion · EU · 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.

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