GSK (GSK) 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, ODD, from the US Food and Drug Administration, FDA, for the treatment of small-cell lung cancer, SCLC. The ODD was supported by preliminary clinical data showing durable responses in patients with extensive stage SCLC, ES-SCLC, who were treated with risvutatug rezetecan in the phase I ARTEMIS-001 clinical trial.
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