Hetronifly - opinion on variation to marketing authorisation

Opinion

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

serplulimab

Opinion

On 26 March 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 Hetronifly. The marketing authorisation holder for this medicinal product isAccord Healthcare S.L.U.

The CHMP adopted a new indication as follows:

Small cell lung cancer (SCLC)

Hetronifly in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC).

Oesophageal squamous cell carcinoma (OSCC)
 

Hetronifly in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5 

For information, the CHMP adopted another new indication on 26 March 2026 for Hetroniflyto extend its use to oesophageal squamous cell carcinoma (OSCC). Information on this change is provided in a dedicated summary of opinionavailable from the EMA website.

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 Hetronifly (VR/0000284402) 

Adopted Reference Number: EMADOC-1700519818-3000971

Key facts

• Name of medicine:
  Hetronifly
• EMA product number:
  EMEA/H/C/006170
• Active substance:
  serplulimab
• International non-proprietary name (INN) or common name:
  serplulimab
• Therapeutic area (MeSH):
  Small Cell Lung Carcinoma
• Anatomical therapeutical chemical (ATC) code:
  L01FF12
• 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:
  Accord Healthcare S.L.U.
• Date of opinion:
  26/03/2026
• Status:
  Positive