GSK: FDA Grants Orphan Drug Designation To GSK'227

(RTTNews) - GSK plc (GSK, GSK.L) announced that its B7-H3-targeted antibody-drug conjugate GSK'227, now referred to by its International Nonproprietary Name, risvutatug rezetecan, has received Orphan Drug Designation from the FDA 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 risvutatug rezetecan in the phase I ARTEMIS-001 clinical trial.

The company said the designation follows the recent announcement that risvutatug rezetecan was granted ODD from the European Medicines Agency for the treatment of pulmonary neuroendocrine carcinoma, a category of cancer that includes SCLC.

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