10th Dec 2025 08:41
GSK PLC - London-based pharmaceutical maker - US regulator the Food & Drug Administration grants orphan drug designation to a GSK treatment for small-cell lung cancer. The designation is for drugs that address a rare disease or condition. It grants benefits including a period of market exclusivity. GSK'227, known as risvutatug rezetecan, already had orphan drug designation from the European Medicines Agency for the treatment of pulmonary neuroendocrine carcinoma, a category that includes small-cell lung cancer. SCLC constitutes about 13% of all lung cancers in the US. Risvutatug rezetecan is a B7-H3-targeted antibody-drug conjugate for which GSK acquired exclusive worldwide rights, excluding greater China, from Jiangsu Hansoh Pharmaceutical Group Co Ltd.
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By Tom Waite, Alliance News editor
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