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GSK announces GSK’227 receives Orphan Drug Designation in EU

GSK (GSK) announced that GSK5764227, GSK’227, its B7-H3-targeted antibody-drug conjugate, ADC, has received Orphan Drug Designation, ODD, from the European Medicines Agency, EMA, for the treatment of pulmonary neuroendocrine carcinoma, NEC, a category of cancer that includes small-cell lung cancer, SCLC. The ODD was supported by preliminary clinical data showing durable responses in patients with extensive stage SCLC, ES-SCLC, who were treated with GSK’227 in the phase I ARTEMIS-001 clinical trial.

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