Henlius receives two positive CHMP opinions recommending serplulimab approval for nsqNSCLC and ESCC in Europe

The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued two positive opinions recommending approval of serplulimab for new indications across 30 European Economic Area countries. The opinions recommend serplulimab in combination with chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung carcinoma. They also recommend the drug in combination with chemotherapy for patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 with a combined positive score of 5 or higher. The recommendations draw from results of the ASTRUM-002 and ASTRUM-007 Phase 3 trials. Under European Union procedures, the opinions will be submitted to the European Commission for a final decision. If approved, the indications for serplulimab would expand in European Union member states and the European Economic Area. Shanghai Henlius Biotech announced the opinions. The company said serplulimab has already received European Union approval for first-line treatment of extensive-stage small cell lung cancer.