GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227, receives orphan drug designation in the EU

CAR-T Digest - August 2020

28 October 2025: GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227, receives orphan drug designation in the EU

GSK’s B7-H3-targeted ADC, GSK5764227 (GSK’227), has received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for treating pulmonary neuroendocrine carcinoma, including SCLC
The designation is backed by encouraging Phase 1 ARTEMIS-001 trial data, showing durable responses in patients with extensive-stage SCLC (ES-SCLC)
This marks the fourth regulatory designation for GSK’227, reinforcing its transformational potential across multiple solid tumours, including lung, colorectal, head and neck, and prostate cancers
The ADC had earlier received EMA PRIME and FDA Breakthrough Therapy designations for ES-SCLC and osteosarcoma, further validating GSK’s accelerated ADC development strategy