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Blueprint Medicines Aims For Genomically Defined GIST Indication With Avapritinib NDA

 
• By Bridget Silverman

Kinome-focused Blueprint Medicines plans to follow up its first NDA, for all lines of therapy in patients with exon 18 mutant GIST or fourth-line use in non-genomically selected patients, with submissions for third-line GIST and advanced systemic mastocytosis in 2020.

Rolled House Blueprints and Construction Plans. - Image

Blueprint Medicines Corp.’s recent submission of its first new drug application for its lead candidate avapritinib could be followed by four more filings in the next 18 months, chief executive officer Jeffrey Albers told a 17 June 2019 conference call. Three of those planned filings include an indication with a breakthrough therapy designation.

The NDA for avapritinib, a highly selective KIT and platelet-derived growth factor receptor alpha (PDGFRA) inhibitor, seeks approval in two populations: adults with exon 18 mutant gastrointestinal stromal tumors regardless of prior therapy and fourth-line GIST

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