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Ongoing JCA

Senaparib (Sepalna): EU joint clinical assessment

Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer

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

Overview

Company
SFL Pharmaceuticals
Therapy area
Solid tumours · Gynaecological
Indication
Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer
Product type
Chemical
EMA validation
14 Aug 2025
JCA assessor
IQWiG, Germany
Co-assessor
Slovenian Quality Health Care Agency, Slovenia
Regulatory status
CHMP positive 18 Sep 2026 (1L maintenance after platinum response). EC decision pending at last check.
Latest
Awaiting EU authorisation; national HTA not started.
Pivotal evidence
FLAMES (phase 3, double-blind; registered sites in China, RCT)
01

Scope

The PICO forecast

JCA Pulse forecasts 3 PICOs for Senaparib, 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

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

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04

Countries

National translator and outlook

Germany and Slovenia 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

  • 18 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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