Delay in review of Blueprint's kinase blocker Ayvakit

7 February 2020

The US regulator has extended the Prescription Drug User Fee Act (PDUFA) action date on a regulatory submission for the kinase inhibitor avapritinib, by three months to May 14, 2020.

Cambridge, Massachusetts-based Blueprint Medicines (Nasdaq: BPMC) is seeking accelerated approval of the candidate, for the treatment of adults with fourth-line gastrointestinal stromal tumor (GIST).

Shares in Blueprint, a precision therapy company focused on genomically-defined cancers, rare diseases and cancer immunotherapy, dipped by over 1% ahead of the opening bell on Friday.

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