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GSK treatment wins orphan drug designation in Japan
(Sharecast News) - A GSK treatment for an aggressive form of small-cell lung cancer has been granted orphan drug designation in Japan, the pharma blue chip announced on Monday. The drug, a B7-HS-targeted antibody-drug conjugate called risvutatug rezetecan (ris-rez), has been approved by Japan's Ministry of Health, Labour and Welfare after preliminary clinical data showed a durable response in patients with extensive-stage SCLC.
An aggressive and difficult-to-treat cancer, extensive-stage SCLC means the cancer has spread throughout one or both lungs and/or to other parts of the body.
It currently has limited treatment options and poor long-term survival.
ODD is granted to drugs designed to treat rare-yet-serious diseases affecting less than 50,000 patients with a high medial need. SCLC makes up 10% to 15% of lung cancer in Japan, GSK said, and of those, 70% have extensive-stage SCLC.
It is the sixth regulatory designation for ris-rez, GSK noted. The treatment is being developed in a range of solid tumours, including lung, prostrate and colorectal cancers.
See latest RNS on Investegate
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