LONDON (dpa-AFX) - 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.
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