FDA Approves Avapritinib for Indolent Systemic Mastocytosis

On May 22, the U.S. Food and Drug Administration (FDA) approved the tyrosine kinase inhibitor avapritinib (Ayvakit) for the treatment of adults with indolent systemic mastocytosis. Avapritinib is the first and only approved therapy for indolent systemic mastocytosis. Systemic mastocytosis is a rare hematologic disorder that can lead to a range of debilitating symptoms across multiple organ systems and can have a significant impact on patients’ quality of life; indolent systemic mastocytosis represents the vast majority of systemic mastocytosis cases. Avapritinib is designed to potently and selectively inhibit KIT D816V, the primary underlying driver of the disease, and has been FDA-approved for the treatment of advanced systemic mastocytosis since June 2021.

Source: The ASCO Post Staff