GSK’sri svutatug rezetecan granted Orphan Drug Designation for small-cell lung cancer in Japan

GSK has recently announced that risvutatug rezetecan, which is a B7-H3-targeted antibody-drug conjugate, has received Orphan Drug Designation from Japan’s Ministry of Health, Labour and Welfare for the treatment of small-cell lung cancer. The ODD was supported by preliminary clinical data showing durable responses in patients with extensive-stage SCLC who were treated with Ris-Rez in the phase I ARTEMIS-001 clinical trial.

Note that lung cancer is the second most common cancer in Japan, and SCLC makes up 10-15% of cases. Of patients with SCLC, 70% have ES-SCLC, meaning the cancer has spread throughout one or both lungs and/or to other parts of the body. ES-SCLC is an aggressive and difficult-to-treat cancer with limited treatment options and poor long-term survival.

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Related Topics and Keywords

GSK, GSK’s B7-H3-targeted antibody-drug conjugate, risvutatug rezetecan, small-cell lung cancer