AP26113 regulatory update

Ariad said FDA granted breakthrough therapy designation for AP26113 to treat anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) in patients who are resistant to crizotinib. Last year, FDA denied granting the designation due to "relatively short follow-up" and the small number of ALK-positive patients. The approval is based on data submitted from an ongoing Phase I/II trial. Updated data from the trial in 72 evaluable patients with ALK-positive NSCLC showed that 52 patients (72%) had an objective response. ...