Ariad Unfazed By FDA Breakthrough Denial

08 Aug 2013

• By Shirley Haley

FDA denied a “breakthrough” designation request for ALK/EGFR inhibitor AP26113, but the door is open for another try, and the undaunted company is launching a pivotal trial in NSCLC this quarter. Ariad also reported a continued successful launch of its leukemia drug Iclusig.

Ariad Pharmaceuticals Inc. was denied a breakthrough designation from FDA for its ALK/EGFR inhibitor AP26113 in non-small cell lung cancer, the company admitted during its second quarter earnings call, though the firm may try again.

The request was denied “because of the relatively short follow-up of many of the ALK-positive patients treated with ‘113 to...