FDA Orphan Drug Designation for Gotistobart in Squamous NSCLC
U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to gotistobart (also known as BNT316 or ONC-392) for the treatment of squamous NSCLC, an aggressive subtype of lung cancer with limited therapeutic options in the advanced stage. Gotistobart is a novel tumor microenvironment-selective regulatory T cell (“Treg”) depletion candidate targeting CTLA-4.
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