Zynyz - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

retifanlimab

Opinion

On 29 January 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Zynyz. The marketing authorisation holder for this medicinal product is Incyte Biosciences Distribution B.V.

The CHMP adopted a new indication as follows:

Squamous cell carcinoma of the anal canal (SCAC)

Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).

Merkel cell carcinoma (MCC)

Zynyz is indicated as monotherapy for the first‑line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Zynyz (EMAVR0000247788)

Adopted Reference Number: EMADOC-1700519818-2841651

Key facts

• Name of medicine:
  Zynyz
• EMA product number:
  EMEA/H/C/006194
• Active substance:
  retifanlimab
• International non-proprietary name (INN) or common name:
  retifanlimab
• Therapeutic area (MeSH):
  Carcinoma, Merkel Cell
• Anatomical therapeutical chemical (ATC) code:
  L01FF10
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Incyte Biosciences Distribution B.V.
• Date of opinion:
  29/01/2026
• Status:
  Positive