Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized avapritinib as a monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the platelet-derived growth factor receptor alpha (PDGFRA) p.D842V variant.

This is written in the approval document as:

AYVAKYT is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.

Citation

Blueprint Medicines (Netherlands) B.V. Ayvakyt (avapritinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/ayvakyt-epar-product-information_en.pdf. Revised February 2024. Accessed March 6, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	PDGFRA p.D842V	Gastrointestinal Stromal Tumor	Avapritinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2020-09-24	European Medicines Agency	Indication received approval from the European Commission.