GSK's Risvutatug Rezetecan Gets FDA's Orphan Drug Tag in Lung Cancer

Key Takeaways GSK's risvutatug rezetecan earns FDA Orphan Drug Designation for treating small-cell lung cancer.The drug also holds FDA Breakthrough and EMA PRIME status supporting accelerated development.Phase III studies are underway following positive ARTEMIS-001 data.GSK plc (GSK) announced that the FDA has granted Orphan Drug Designation to GSK’227, its investigational B7-H3-targeted antibody-drug conjugate (“ADC”), for the treatment of small-cell lung cancer (SCLC). GSK’227 has now been renamed risvuta ...