Blueprint Medicines’ Ayvakit (avapritinib) Receives FDA’s Approval to Treat Patients with Advanced Systemic Mastocytosis

June 17, 2021 Auto Bot approval, blueprint-medicines, FDA, regulatory 0

Shots:

  • The full FDA approval is based on data from 2 clinical trials i.e., P-I EXPLORER & P-II PATHFINDER trial evaluating the efficacy of Ayvakit (200 mg, PO, qd) in 53 adults with advanced SM including ASM, SM-AHN & MCL
  • Results: @median follow-up of 11.6 mos., ORR (57%), CR/CRh (28%), PR (28 %) & clinical improvement (15%), m-DoR (38.3 mos.). Treatment response was evaluated using modified IWG-MRT-ECNM criteria & additional efficacy measures are DoR, resolution, >50% reductions in biomarker response, mast cell burden & serum tryptase
  • Ayvakit is not recommended for patients with low platelet counts (<50,000/µL). This approval marks the 1st targeted therapy that inhibits D816V mutant KIT

Click here to­ read full press release/ article | Ref: Blueprint Medicines | Image: PR Newswire

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