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
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