Indications of Avapritinib

1. Unresectable or metastatic gastrointestinal stromal tumors (GIST) positive for PDGFRA exon 18 mutations

AYVAKIT® is indicated for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutations, including PDGFRA D842V mutations.

2 .Advanced systemic mastocytosis (AdvSM)

AYVAKIT is indicated for the treatment of adult patients with advanced systemic mastocytosis (AdvSM). Advanced systemic mastocytosis (AdvSM) includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL).Use Limitation: AYVAKIT is not recommended for patients with advanced systemic mastocytosis (AdvSM) who have a platelet count below 50×10⁹/L.

3. Indolent systemic mastocytosis (ISM)

AYVAKIT is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM).

Use Limitation: AYVAKIT is not recommended for patients with indolent systemic mastocytosis (ISM) who have a platelet count below 50×10⁹/L.

FDA，2024.11