The U.S. Food and Drug Administration (FDA) granted the investigational cancer drug AP26113, being developed by Ariad Pharmaceuticals, Breakthrough Therapy status. The treatment is meant for patients suffering from anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) that are resistant to crizotinib. The FDA decision was based on the recently released positive results of the ongoing phase 2 clinical trials.
The Breakthrough Therapy designation granted to AP26113 is meant to accelerate the development and review of the drug, according to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). The status was given based on the believe that Ariad’s therapy may represent a substantial improvement over current treatments for patients suffering from lung cancer.
“We are very pleased that the FDA has granted Breakthrough Therapy designation to AP26113,” chairman and chief executive officer of Ariad, Harvey Berger said in a company’s press release.“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.”
Ariad Pharmaceuticals is currently conducting its phase 1/2 clinical trial, which have already revealed the effectiveness of the drug in ALK+ NSCLC patients, as well as in patients who were either TKI-naïve or resistant to crizotinib. The median duration of the objetive response demonstrated was 49 weeks, and the median progression-free survival (PFS) 56 weeks. The study included 137 patients across the Unites States and Europe and the findings were presented at the 2014 European Cancer Congress.
The company also reported that among the total number of patients enrolled in the trial, 45% suffered nausea, 37% diarrhea and 37% fatigue, as adverse events. In addition, other events such as dyspnea, increased lipase, hypoxia, alanine aminotransferase (ALT) increase and amylase increase were also reported, albeit less frequent.