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Ongoing JCA

Rezvilutamide: EU joint clinical assessment

Treatment of high-volume metastatic hormone-sensitive prostate cancer in adults

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

Overview

Company
Hengrui
Therapy area
Solid tumours · Prostate
Indication
Treatment of high-volume metastatic hormone-sensitive prostate cancer in adults
Product type
Chemical
EMA validation
18 Jun 2026
JCA assessor
ZIN, The Netherlands
Co-assessor
NCPE, Ireland
Regulatory status
Under EMA review.
Pivotal evidence
CHART (phase 3, open-label; China, PL, CZ, BG, RCT)
01

Scope

The PICO forecast

JCA Pulse forecasts 2 PICOs for Rezvilutamide, with 2 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

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

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04

Countries

National translator and outlook

Netherlands and Ireland 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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