FDA approves avapritinib for treatment of adults with advanced systemic mastocytosis (SM)
SM is a rare hematologic disorder caused by the KIT D816V mutation in nearly all cases. Approval of this kinase inhibitor is for use across aggressive SM, SM with an associated haematological neoplasm and mast cell leukaemia.
Source:
Biospace Inc.
SPS commentary:
Avapritinib is already approved in US for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumours. In March 2021 the European Medicines Agency validated a type II variation marketing authorisation application for avapritinib for treatment of advanced SM.