Regulatory approval

Published by the European Medicines Agency.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PDGFRA p.D842V	Gastrointestinal Stromal Tumor	Avapritinib