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.

Pa­tients on re­go­rafenib did bet­ter than those on Ay­vak­it. Af­ter the tri­al, Blue­print said they were end­ing the pro­gram for 3rd and 4th line GIST pa­tients. An­a­lysts dis­count­ed the in­di­ca­tion from their pro­jec­tions.

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