After a PhIII failure, the FDA delivers Blueprint an expected CRL

Some CRLs come as little surprise.

This morning, the FDA rejected Blueprint Medicines’ application to have their cancer drug Ayvakit (avapritinib) approved for fourth-line gastrointestinal stromal tumors, or GIST. Already, though, in late April, the drug had failed the major test for that indication: A Phase III trial pitting Ayvakit against the already-approved Bayer GIST drug, regorafenib.