Ayvakyt receives positive CHMP opinion for the treatment of adults with advanced systemic mastocytosis- Blueprint Medicines.
The CHMP based its opinion on results from the Phase 1 EXPLORER trial and Phase II PATHFINDER trial, in which Ayvakyt showed durable clinical efficacy in advanced SM patients across disease subtypes and a generally well-tolerated safety profile. These two studies, which enrolled approximately 150 patients with up to four years of follow-up and comprise the largest ever reported dataset in advanced systemic mastocytosis, were recently published in Nature Medicine. ( previously cited).
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