Tag Archives: PRIME designation

GSK secures Japan orphan drug designation for risvutatug rezetecan advancing treatment options in small-cell lung cancer

(IN BRIEF) GSK plc has received Orphan Drug Designation in Japan for its investigational antibody-drug conjugate risvutatug rezetecan (Ris-Rez) for the treatment of small-cell lung cancer, supported by early clinical data showing durable responses in patients with extensive-stage disease. SCLC, … Read the full press release

GSK Receives EMA Orphan Drug Designation for GSK’227 in Small-Cell Lung Cancer, Strengthening Its ADC Oncology Pipeline

(IN BRIEF) GSK announced that its B7-H3-targeted antibody-drug conjugate GSK5764227 (GSK’227) has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of pulmonary neuroendocrine carcinoma, including small-cell lung cancer (SCLC). The designation is supported … Read the full press release