• Alectinib received FDA priority review designation for first-line treatment of patients with ALK-positive, locally advanced or metastatic NSCLC. The supplemental new drug application included results from the phase III ALEX and J-ALEX studies, which were designed to evaluate alectinib as first-line treatment for patients with ALKpositive, locally advanced or metastatic NSCLC as detected by an FDA-approved test. (8/03/17)
• Durvalumab (Imfinzi) received FDA breakthrough therapy designation for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC). This designation was based on interim results of the randomized phase III PACIFIC trial. The double-blind, placebocontrolled, multicenter study evaluated durvalumab as a sequential treatment for patients with locally advanced, unresectable NSCLC whose disease had not progressed after standard platinum-based chemotherapy with adjuvant radiation therapy. (7/31/17)
• Pembrolizumab received from the Scottish Medicines Consortium for routine use in treatment of advanced NSCLC. Approximately 5,000 cases of lung cancer are diagnosed annually in Scotland, which makes its incidence there among the highest in the world. Lung cancer in Scotland is also the most frequent type of cancer diagnosed compared with cancer incidence rates rest of the United Kingdom. (07/10/17)
