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JCA Pulse › Ongoing JCA

Ongoing JCA

Daraxonrasib: EU joint clinical assessment

Metastatic pancreatic adenocarcinoma

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

Overview

Company
Revolution Medicines
Therapy area
Solid tumours · Gastrointestinal
Indication
Metastatic pancreatic adenocarcinoma
Product type
Chemical, Orphan designation
EMA validation
Under EMA phased review
JCA assessor
IQWiG, Germany
Co-assessor
Danish Medicines Council, Denmark
Regulatory status
MAA under EMA phased review (not yet validated at 15 Oct 2026).
Pivotal evidence
RASolute 302 (phase 3, open-label, RCT)
01

Scope

The PICO forecast

JCA Pulse forecasts 1–2 PICOs for Daraxonrasib, with 4 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

Daraxonrasib’s pivotal evidence (RASolute 302) 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 Daraxonrasib dossier and projects the indirect comparison each comparator will need.

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04

Countries

National translator and outlook

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

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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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