Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PDGFRA p.D842V status confers therapeutic sensitivity to Avapritinib in patients with Gastrointestinal Stromal Tumor.

The U.S. Food and Drug Administration granted approval to avapritinib for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.

This statement is based on a regulatory approval from the Food and Drug Administration:

AYVAKIT is a kinase inhibitor indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.

Citation

Blueprint Medicines Corporation. Ayvakit (avapritinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212608s013lbl.pdf. Revised May 2023. Accessed October 30, 2024. Blueprint Medicines Corporation. Ayvakit (avapritinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s007lbl.pdf. Revised June 2021. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2021-06-16	Food and Drug Administration	Indication received traditional approval.