Ariad's Investigational NSCLC Drug: Breakthrough by FDA

The molecule is being evaluated in crizotinib-resistant ALK-positive NSCLC patients. The results from the phase 1/2 trial with AP26113 were presented at the 2014 European Cancer Congress.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that its investigational cancer medicine, AP26113, has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib. This 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.

“We are very pleased that the FDA has granted Breakthrough Therapy designation to AP26113,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “We are encouraged by the clinical data on AP26113 that were presented recently at the European Cancer Congress, particularly in patients whose tumor had spread to the brain. We are focused on accelerating patient enrollment in the ongoing ALTA trial and on planning a front-line trial of AP26113 in treatment-naive patients.”

Link to Ariad's press release:

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