Blueprint Medicines Receives the US FDA’s Acceptance of sNDA for Ayvakit (avapritinib) to Treat Indolent Systemic Mastocytosis


The US FDA has accepted the sNDA for Ayvakit (avapritinib) to treat adult patients with indolent systemic mastocytosis. Priority review was granted by the US FDA with a PDUFA action date of May 2023
The application was based on the (PIONEER) trial results evaluating the safety and efficacy of BLU-285 in 251 patients with Indolent Systemic Mastocytosis inadequately controlled with standard therapy
Ayvakit (kinase inhibitor) has received BTD from the US FDA for the treatment of mod. to sev. indolent SM & has been approved in the US for adults with advanced SM, incl. aggressive SM, SM-AHN, MCL & adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation

Ref: PRNewswire | Image: Blueprint Medicines

Related News:- Blueprint Medicines Reports (PIONEER) Trial Results of Ayvakit (avapritinib) for the Treatment of Non-Advanced Systemic Mastocytosis