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GSK plc announced that the FDA has granted Orphan Drug Designation to GSK’227, now renamed risvutatug rezetecan, for the treatment of small-cell lung cancer (SCLC). This designation supports the drug’s development for rare diseases, affecting fewer than 200,000 people in the U.S. The designation follows promising results from the phase I ARTEMIS-001 study, indicating durable responses in patients with extensive-stage SCLC.
A phase III study evaluating risvutatug rezetecan in relapsed SCLC began in October 2025. Another phase III study is assessing the drug for osteosarcoma. The European Medicines Agency (EMA) also granted Orphan Drug Designation to risvutatug rezetecan for pulmonary neuroendocrine carcinoma. In the U.S., SCLC represents about 13% of all lung cancers, with a notably poor prognosis for extensive-stage patients.
GSK has exclusive global rights (excluding mainland China) to risvutatug rezetecan, licensed from Hansoh Pharma in December 2023.
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