GSK's Risvutatug Rezetecan Gets Japan Orphan Drug Tag for Lung Cancer

Key Takeaways GSK wins Japan orphan drug status for risvutatug rezetecan in small-cell lung cancer.GSK's phase I ARTEMIS-001 showed durable responses in extensive-stage SCLC patients.The candidate also holds FDA Breakthrough and EMA PRIME status, supporting accelerated development.GSK plc (GSK) announced that Japan’s Ministry of Health, Labour and Welfare has granted Orphan Drug Designation (ODD) to risvutatug rezetecan, its investigational B7-H3-targeted antibody-drug conjugate (“ADC”), for the treatment o ...