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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER