EMA's Advisory Committee Recommends Approval Of Blueprint Medicines' Avapritinib In Blood Disorder

Vandana Singh
1 min read
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The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the use of Blueprint Medicines Corporation's (NASDAQ: BPMC) Ayvakyt (avapritinib).

  • The positive opinion covers Ayvakyt as monotherapy for aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) after at least one systemic therapy.

  • A final decision on the application to expand the indication for Ayvakyt is anticipated by early April 2022.

  • Related: Blueprint Medicines Expands Precision Therapy With Lengo Therapeutics Acquisition.

  • The CHMP based its opinion on results from the Phase 1 EXPLORER trial and Phase 2 PATHFINDER trial.

  • Ayvakyt showed durable clinical efficacy in advanced SM patients across disease subtypes and a generally well-tolerated safety profile.

  • These two studies enrolled approximately 150 patients with up to four years of follow-up.

  • Price Action: BPMC shares are down 1.36% at $69.16 during the market session on the last check Friday.

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