Blueprint Medicines Corporation announced the European Commission has approved AYVAKYT (avapritinib) for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment. AYVAKYT is the first and only approved therapy for people living with ISM in Europe. In Europe, Blueprint Medicines plans to initiate its first commercial launch in Germany, followed by additional markets based on local healthcare technology assessment and reimbursement process timelines.

AYVakYT (avapritinib), is a kinase inhibitor approved by the European Commission for the treatment of three indications: adults with indolent systemic mastocosis (ISM), adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN) or mast cell leukemia (MCL), after at least one systemic therapy, and adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the PDGFRA D842V mutation. Under the brand name AYVAKIT, the medicine is approved in the U.S. for the treatment of adults with ISM, adults with advanced SM, including ASM, SM-AHN and MCL, and adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D8 42V mutations.