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GSK plc announced that risvutatug rezetecan (Ris-Rez), a B7-H3-targeted antibody-drug conjugate, received Orphan Drug Designation from Japan's Ministry of Health, Labour and Welfare for small-cell lung cancer (SCLC). The designation, supported by phase I ARTEMIS-001 trial data showing durable responses in extensive-stage SCLC, marks the sixth global regulatory designation for Ris-Rez.
Key Takeaways
1Risvutatug rezetecan granted Orphan Drug Designation for SCLC by Japan's Ministry of Health, Labour and Welfare.
2Designation supported by preliminary phase I ARTEMIS-001 data showing durable responses in extensive-stage SCLC patients.
3Sixth regulatory designation for Ris-Rez, including FDA ODD for SCLC, EMA ODD for pulmonary neuroendocrine carcinoma, EMA PRIME for relapsed/refractory ES-SCLC, and FDA Breakthrough Therapy Designations for relapsed/refractory ES-SCLC and osteosarcoma.
4GSK's phase III trial (NCT07099898) for Ris-Rez in relapsed ES-SCLC began in August 2025.
5GSK acquired exclusive worldwide rights to Ris-Rez from Hansoh Pharma, excluding mainland China, Hong Kong, Macau, and Taiwan.