FDA Breakthrough designation for Ariad’s AP26113

US specialty pharma firm Ariad Pharmaceuticals (Nasdaq: ARIA) says that its investigational cancer drug AP26113 has received Breakthrough Therapy designation by the US Food and Drug Administration for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib (Pfizer's Xalkori).

This designation is based on results from the ongoing Phase I/II trial that show sustained anti-tumor activity of AP26113 in patients with ALK+ NSCLC, including patients with active brain metastases. Ariad’s shares gained 10.8% to $5.85 on the news.

“We are very pleased that the FDA has granted Breakthrough Therapy designation to AP26113,” stated Harvey Berger, chairman and chief executive of Ariad, adding: “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.”