Posted by Michael Wonder on 30 Jan 2022
Blueprint Medicines' Ayvakyt (avapritinib) receives positive CHMP opinion for the treatment of adults with advanced systemic mastocytosis
28 January 2022 - Positive opinion based on results from two clinical trials that comprise the largest clinical trial dataset in advanced systemic mastocytosis.
Blueprint Medicines today announced that the CHMP of the EMA has adopted a positive opinion, recommending to expand the current indication for Ayvakyt (avapritinib) to include monotherapy for the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm or mast cell leukaemia after at least one systemic therapy.
