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Ongoing JCA

Fuzuloparib: EU joint clinical assessment

Treatment of adult patients with metastatic castration-resistant prostate cancer

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

Overview

Company
Hengrui
Therapy area
Solid tumours · Prostate
Indication
Treatment of adult patients with metastatic castration-resistant prostate cancer
Product type
Chemical
EMA validation
01 Oct 2026
JCA assessor
IQWiG, Germany
Co-assessor
ZIN, The Netherlands
Regulatory status
Under EMA review (validated Oct 2026).
Pivotal evidence
FUZUPRO (phase 3, double-blind; with abiraterone-prednisone, RCT)
01

Scope

The PICO forecast

JCA Pulse forecasts 2–3 PICOs for Fuzuloparib, with 7 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

Fuzuloparib’s pivotal evidence (FUZUPRO) 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 Fuzuloparib dossier and projects the indirect comparison each comparator will need.

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04

Countries

National translator and outlook

Germany and Netherlands 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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