FDA Grants Breakthrough Therapy Designation for First-Line Treatment of ALK-Positive NSCLC

On October 4, 2016, the U.S. Food and Drug Administration (FDA) granted alectinib, an anaplastic lymphoma kinase (ALK) inhibitor, a second Breakthrough Therapy designation. This latest designation was granted for the treatment of adult patients with advanced ALK-positive non–small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor, based on results of the J-ALEX trial. “The J-ALEX study that supports the second Breakthrough Designation for alectinib showed superior efficacy vs the standard of care, crizotinib, in Japanese [patients] with advanced … (leggi tutto)