CStone Pharmaceuticals (HKG:2616) submitted a Type II variation application to the European Medicines Agency (EMA) for a new indication of sugemalimab in stage III non-small cell lung cancer (NSCLC).
The application pursues approval for treating patients with unresectable stage III NSCLC who have not progressed following concurrent or sequential platinum-based chemoradiotherapy.
The drug previously received approval in Europe for metastatic squamous and non-squamous NSCLC in 2024, according to a Monday filing with the Hong Kong bourse.
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