Ariad's Lung Cancer Gets FDA Breakthrough Therapy Designation

(RTTNews) - Ariad Pharmaceuticals, Inc. (ARIA) said Thursday that its investigational cancer medicine, AP26113, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration for the treatment of patients with anaplastic lymphoma kinase positive metastatic non-small cell lung cancer who are resistant to crizotinib.

The designation is based on results from the ongoing Phase 1/2 trial that show sustained anti-tumor activity of AP26113 in patients with ALK+ NSCLC, including patients with active brain metastases.

The 2012 Food and Drug Administration Safety and Innovation Act established the Breakthrough Therapy designation to expedite the development and review of new drugs with preliminary clinical evidence demonstrating that they may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. The Breakthrough Therapy designation is a distinct status from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria are met.