Blueprint Medicines: EU Approves AYVAKYT For Treatment Of Adults With Advanced Systemic Mastocytosis

(RTTNews) - Blueprint Medicines Corp. (BPMC) said Friday that the European Commission has expanded the current indication for AYVAKYT (avapritinib) to include monotherapy for the treatment of adult patients 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.

Initial commercial launch is planned for Germany immediately following the European Commission approval.

AYVAKYT will be available in 25 mg, 50 mg, 100mg and 200mg dose strengths, and the recommended starting dose in advanced Systemic mastocytosis or SM is 200 mg once daily.

Advanced Systemic Mastocytosis is a debilitating disease characterized by damage across multiple organ systems, reduced overall survival and poor quality of life.