Bezuclastinib

Bezuclastinib remains investigational in the regulatory evidence reproduced here. The FDA review announcement gives a December 30, 2026 target action date. SUMMIT provides placebo-controlled evidence of symptom and biomarker improvement, with transaminase elevations contributing to treatment discontinuation. The effect of KIT inhibition on disease progression remains uncertain. Comparator avapritinib evidence does not establish a direct comparison with bezuclastinib.