LONDON (dpa-AFX) - GSK plc (GSK, GSK.L) announced that its investigational B7-H3-targeted antibody-drug conjugate, GSK5764227 or GSK'227, has received Orphan Drug Designation from the European Medicines Agency (EMA). The designation is for the treatment of pulmonary neuroendocrine carcinoma (NEC), a rare and aggressive group of cancers that includes small-cell lung cancer (SCLC).
This is the fourth regulatory designation for GSK'227, exemplifying the potential of this targeted ADC, which is being developed in a range of solid tumour types, including in lung, prostate and colorectal cancers. Previously, GSK'227 was granted Priority Medicines (PRIME) designation by the EMA for relapsed or refractory ES-SCLC and Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma granted by the US FDA.
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