Alecensa alectinib regulatory update

FDA granted breakthrough therapy designation to Alecensa alectinib from Roche to treat anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients who have not received prior treatment with an ALK inhibitor. The designation was based on the open-label, Japanese Phase III J-ALEX trial (see BioCentury, Feb. 15 & May 23). The ALK inhibitor has accelerated approval in the U.S. to treat ALK-positive, metastatic NSCLC in patients who have progressed on or are intolerant to Xalkori crizotinib. An MAA is under EMA review for the product. ...