Blueprint Medicines’ Ayvakit (avapritinib) Receives the US FDA’s Approval as the First Treatment for Indolent Systemic Mastocytosis
Shots:
- The approval was based on the (PIONEER) trial evaluating Ayvakit (25mg, qd) + BSC vs PBO + BSC in 251 patients
- The results showed an improvement in the 1EPs & 2EPs incl. overall symptoms & measures of mast cell burden, was well-tolerated with a favorable safety profile, patients completed their treatment (96% vs 93%), AEs (90.8% vs 93%) & SAEs (5% vs 11.3%)
- The (PIONEER) trial results, incl. an OLE study showed the clinical benefits of Ayvakit @48wks., presented at AAAAI 2023. The therapy was approved in the US for 3 indications i.e., ISM, SM & unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation & EU for ASM, SM-AHN or MCL & unresectable or metastatic GIST harboring the PDGFRA D842V mutation
Ref: Blueprint Medicines | Image: Blueprint Medicines
Related News:- Blueprint Medicines Presents P-II Trial (PIONEER) of Ayvakit (avapritinib) for Indolent Systemic Mastocytosis at AAAAI 2023
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
