Hetronifly - opinion on variation to marketing authorisation Opinion EMA has issued an opinion on a change to this medicine's authorisation serplulimab Post-authorisation Human 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). 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 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. Note: New text in bold CHMP post-authorisation summary of positive opinion for Hetronifly (VR/0000282407) Adopted Reference Number: EMADOC-1700519818-2975996 English (EN) (146.19 KB - PDF) First published: 27/03/2026 View 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 News on Hetronifly Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026 27/03/2026 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2024 20/09/2024 More information on Hetronifly Hetronifly This page was last updated on 27/03/2026 Share this page