Accord Healthcare Limited (Accord) today announced that the European Commission (EC) has officially approved the anti-PD-1 mAb serplulimab, marketed in Europe as Hetronifly®, for use in combination with carboplatin and etoposide as a first-line treatment for ES-SCLC.
This makes it the first anti-PD-1 monoclonal antibody approved in Europe for the treatment of ES-SCLC.
Serplulimab was developed by Henlius Biotech. In 2023, Henlius entered into a collaboration with Intas Pharmaceuticals, granting Intas the exclusive rights to develop and market serplulimab in over 50 countries in Europe and India. This latest approval applies to all 27 EU member states, as well as European Economic Area countries, including Norway, Iceland, and Liechtenstein. Marketing in Europe will be led by Accord.
In December 2022, serplulimab received Orphan Drug Designation from the European Commission for the treatment of SCLC; this was recently reviewed and renewed by the committee.
ESMO rates serplulimab at 4 out of 5 on its scale for clinical benefit (MCBS) in ES-SCLC.
