-+ 0.00%
-+ 0.00%
-+ 0.00%

GSK Wins US FDA's Orphan Drug Designation for Small-cell Lung Cancer Treatment

MT Newswires·12/10/2025 02:28:27
Listen to the news
02:28 AM EST, 12/10/2025 (MT Newswires) -- The US Food and Drug Administration granted orphan drug designation to GSK's (GSK.L) B7-H3-targeted antibody-drug conjugate risvutatug rezetecan for the treatment of small-cell lung cancer. The regulator's decision is backed by preliminary data from the phase 1 Artemis-001 trial, which showed "durable" responses in patients treated with the antibody-drug conjugate, according to a Wednesday filing. The British drugmaker previously secured the European Medicines Agency's orphan drug designation for risvutatug rezetecan in the treatment of pulmonary neuroendocrine carcinoma.