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.
