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Ongoing JCA

Bifikafusp alfa / onfekafusp alfa (Nidlegy): EU joint clinical assessment

Neoadjuvant treatment of adult patients with melanoma

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

Overview

Company
Philogen
Therapy area
Solid tumours · Skin
Indication
Neoadjuvant treatment of adult patients with melanoma
Product type
Biological
EMA validation
13 Aug 2026
JCA assessor
TLV, Sweden
Co-assessor
AOTMiT, Poland
Regulatory status
Resubmitted MAA (validated 13 Aug 2026) after 2025 withdrawal; under EMA review.
Pivotal evidence
PIVOTAL (phase 3, open-label, RCT)
01

Scope

The PICO forecast

JCA Pulse forecasts 1–2 PICOs for Bifikafusp alfa / onfekafusp alfa, 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

Bifikafusp alfa / onfekafusp alfa’s pivotal evidence (PIVOTAL) 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 Bifikafusp alfa / onfekafusp alfa dossier and projects the indirect comparison each comparator will need.

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04

Countries

National translator and outlook

Sweden and Poland 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.

From Evidaxia

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