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 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 statement is based on a regulatory approval from the European Medicines Agency:
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.