GSK plc (GSK) said Monday that Japan's Ministry of Health, Labour and Welfare has granted Orphan Drug Designation (ODD) to risvutatug rezetecan (Ris-Rez) for the treatment of small-cell lung cancer (SCLC).
The designation was supported by preliminary results from the phase I ARTEMIS-001 trial, which showed durable responses in patients with extensive-stage SCLC treated with Ris-Rez.
This marks the sixth regulatory designation for the therapy, which is being developed across a range of solid tumours, including lung, prostate and colorectal cancers.
GSK holds exclusive worldwide rights to develop and commercialise Ris-Rez—excluding mainland China, Hong Kong, Macau and Taiwan—under an agreement with Hansoh Pharmaceutical Group.
A phase III trial of Ris-Rez in relapsed extensive-stage SCLC is underway.
For comments and feedback contact: editorial@rttnews.com
Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.