Hetronifly - opinion on variation to marketing authorisation

Opinion

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

serplulimab

Opinion

On 21 May 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 is Accord Healthcare S.L.U.

The CHMP adopted a new indication as follows:

Hetronifly in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma.

For information, the full indications for Hetronifly will be 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).

Non-small cell lung carcinoma (NSCLC)

• Hetronifly in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have:
  • locally advanced NSCLC who are not candidates for surgery or radiotherapy, or
  • metastatic NSCLC.
• Hetronifly in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma.

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.

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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New indication in bold.

CHMP post-authorisation summary of positive opinion for Hetronifly (VR/0000290021)

Adopted Reference Number: EMADOC-1700519818-3134638

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
  • Carcinoma, Non-Small-Cell Lung
  • Esophageal Squamous Cell 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.

• Marketing authorisation holder:
  Accord Healthcare S.L.U.
• Date of opinion:
  21/05/2026
• Status:
  Positive