Theseus Pharmaceuticals receives US FDA Orphan Drug Designation for THE-630 to treat Advanced Gastrointestinal Stromal Tumours (GIST)
For patients living with GIST, progression through standard lines of therapy is often associated with the emergence of resistance mutations in KIT
Theseus Pharmaceuticals recently announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the company’s lead candidate THE-630, a small-molecule oral pan-variant KIT inhibitor, for the treatment of patients with advanced gastro-intestinal stromal tumours (GIST).
“We are pleased to have received ODD for THE-630 so quickly after the initiation of the first-in-human trial. This designation from the FDA emphasises the need to bring better therapeutic options to patients with advanced GIST,” said David Kerstein, MD, Chief Medical Officer (CMO), Theseus.
“For patients living with GIST, progression through standard lines of therapy is often associated with the emergence of resistance mutations in KIT. We look forward to evaluate the clinical potential of THE-630 to inhibit these resistance mutations in patients who’ve exhausted available therapies and when used in earlier lines of therapy.”
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